Jobs That Crossed My Desk Through Feb. 24, 2013 Complimentary Service of Audreysnetwork.com

Feb. 24, 2013

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org.

******************************************************** Check out website at Cepheid Posted by Ron Bucher, Customer Support and Services Executive Senior Service Repair Technician in Sunnyvale Will repair IVD instruments in our HQ repair lab (little or no travel). This position might be a good first job opportunity for a recent college graduate who has a technical degree (biology or engineering) and is adept at repairing equipment. Company has great technology and a very bright future. Great place for career growth. ______________________________________________________________ Senior Service Coordinator (dispatcher) in Sunnyvale QAD experience is a big plus. World class customer support experience required. ________________________________________________________ Service Logistics Manager in Sunnyvale Information systems knowledge must be very strong. ********************************************************* Posted by Taylor Langston, Social Media & Sales Support Specialist at PharmacyWeek, Inc. Like · Flag

Quality Control Coord, CAPS, San Diego, CA (BS/BA Biology, Microbiology, Chemistry, Pharmacy)

http://www.pharmacyweek.com/career/26306/Quality-Control-Coordinator-San-Diego-Ca-California-Ca-San-Diego

*********************************************************** Posted by Giovanni Lauricella, Medical Device Search Consultant at The Mullings Group

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I would like to share more information with you. Please send me a copy of your resume to Giovanni@MullingsGroup.com VP of Medical & Clinical Affairs – Bay Area – Hematology Biologics/Device Ground breaking biologic company based in the Bay has discovered a proactive procedure for blood transfusion. We are looking for a VP of Medical & Clinical Affairs. Must have: • MD degree • Phase III clinical trial experience • Willing to travel 30% internationally • Hematology or oncology experience *************************************************************** Posted by Shelly Glasgow, Technical Recruiter at ProPharma Group Quality Engineer (APR) Consultant - Bay area Now hiring: Multiple Quality Engineer (APR) Consultants - Bay area. For immediate consideration, apply online at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Quality-Engineer-APR-Consultant-Bay-area/3a2c7d30/?source=social-linkedin-group-jobs ********************************************** If you are qualifiied and interested in this role please contact me privately at dave@alpinesearch.net. Due to the volume of replies only qualified respondents will be contacted. Dave Murphy The Alpine Group.

Molecular Diagnostics Marketing Director - Bay area

A high growth Molecular Diagnostics client of mine is expanding and hiring a Director for their clinical marketing team. The Business Unit grew 70% in 2012 and exceeded forecast by 10%. The Director will lead a franchise of Molecular Genetics products used in clinical applications, and the role will include both upstream and downstream marketing duties. The marketing team is small with few layers so this will be a very broadly defined assignment where you will "wear a lot of hats." Qualifications: 8+ years of upstream and downstream marketing experience in the Life Science industry 5+ years of marketing experience in Molecular Diagnostics or Genetic Testing with products / services for clinical applications Expertise in Genetics / Molecular Biology tools and techniques Bachelor's degree in the Life Sciences is required; advanced degree is preferred

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Apply on company website Commercial Leader, Americas Region Onyx Pharmaceuticals- REMOTE (San Francisco Bay Area) Job Description Responsible for the management, oversight, and direction of the operations in the Americas region, including responsibility to interface and manage the distributors partnerships, operational performance, drive sales and market share growth, profitability, and contractual compliance.

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Essential/Primary Duties, Functions and Responsibilities:

Supports corporate development and regional leadership teams in the analyses and evaluation process of partners and distributors in the Americas region

Assists in the development and oversees the execution of the regional commercial strategy and annual plans

Partners with distributors to create market overviews, market development, product launch, marketing plans and sales forecasts

Evaluates distributor performance and tracks against agreed metrics and distributor agreement

Leads Onyx cross regional execution team for America’s to meet regional goals and corporate objectives.

Evaluates and projects scenarios for optimizing Onyx portfolio value in the region. Develops business plans and trigger analysis for step wise affiliates (e.g. Brazil)

Closely manages and tracks budget for the region Tracks planning and implementation of product launch and other key marketing

activities Keeps abreast of changing market trends and opportunities to enhance revenue stream

and market share growth in each country Influences and motivates local distributor/partners teams to exceed sales and

profitability expectations Supports transfer of product knowledge to distributors by helping assess needs, deliver

training programs and overview the creation of marketing materials In partnership with local distributors provide appropriate scientific and marketing

support for key events including but not limited to advisory boards, launch symposium, new indication reviews, competitive positioning, managing pricing within regional & global pricing agreements etc.

Monitors compliance of distributors with relevant laws, regulations, company policies and terms of contract

Collaborates with cross-functional teams, including global product strategy, US sales, finance, clinical development, medical affairs, training, regulatory and others

Develops and delivers presentations as needed to commercial management and other internal groups

Desired Skills & Experience Requirements Work Experience:

10+ years of work experience in product marketing, field sales, strategic planning, finance or management consulting in the pharmaceutical/biotech industry, with at least 5 years in Latin American markets

Experience in market assessment, commercial planning, forecasting and product launch in foreign markets required

3+ years of oncology experience preferred Management of Staff: No direct reports upon hire Functional/Technical Knowledge & Skills:

Strategic thinking with the ability to formulate, develop and execute comprehensive plans

Excellent organizational, analytical and problem solving skills Successfully handle multiple tasks concurrently Ability to prioritize, plan, work independently and take responsibility for commercial and

operational issues Demonstrated ability to communicate effectively (both orally and written) and work well

in cross-functional and multi-cultural teams

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Proven ability to influence without line authority Ability to develop and maintain strong, professional relationships Proficiency in personal computer applications, including the creation of financial models,

forecasts, and P&Ls Customer & Industry Knowledge:

Comprehensive knowledge of the pharmaceutical industry Deep understanding of the competitive environment and relevant laws and regulations

in Latin American markets Understanding of managed care and reimbursement issues preferred

Education/Training: Bachelor’s degree required MBA (or other advanced degree) strongly preferred Bi-lingual (English/Spanish); knowledge of Portuguese desired

Other Requirements: Ideal candidate should live in US, in a major market with adequate airline service to

Latin America Willingness and ability to travel ~50% of time Highly motivated individual, able to be succeed in a rapidly changing, small company

environment Competencies

Strategic thinking Deep understanding of science and product development Oncology market expertise Cross-functional leadership Planning and organizational skills Team leadership, team development and team motivation

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Pharmaceuticals Job ID:4949413

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Apply on company website Director, Scientific Partnerships (US/ROW, New Txs, New Geography, New Products) Onyx Pharmaceuticals- Corporate Office - South San Francisco (San Francisco Bay Area) Job Description Summary The Director of Scientific Partnerships is responsible for global (US, EU and ROW) strategic initiatives with HCPs/investigators/thought leaders to include engagement plans, congress planning for KOL engagements, advisory boards and Investigator Forums. He/she will partner

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with corporate communication as a medical resource to the external advocacy groups and for associated activities. The candidate will act as a liaison to clinical and medical organizations to support the strategy including significant academic institutions, large community research sites and research cooperatives. The function may oversee IME/Grants that supports overall scientific strategy & communication. Essential/Primary Duties, Functions and Responsibilities Engage global thought leaders to develop advocacy, awareness, education and research for Onyx proteasome inhibitors (PIs) in current and emerging indications/disease states, new geographies and new products. (US/ROW (as defined as non EU new geographies – New tumors/indications, new products) Lead KOL Strategy to include a strategic plan, identification/profiling, individual engagement plans, congress KOL sub team and implementation of coordinated KOL engagements (Asia Pac, Americas/Canada, and expansion geographies)

Differentiate Onyx PIs as the preferred proteasome inhibitors and establish Onyx as the scientific partner of choice through innovative initiatives, coordinated strategy and scientific communication

Develop and oversee innovative programs that meet scientific interests for KOLs/investigators/key customers and Onyx (i.e. Visiting Professor Days to Onyx, INTERSECT program for Onyx to visit key centers, Global Investigator Forums in ROW or maybe EU, PRISM NTP (Novel Therapies Program) a global research collaboration to combine pipeline with novel compounds)

Create and integrate plans for cooperative groups and research networks in the US, Europe and in expansion geographies

Partner with Advocacy to develop strategic and tactical plan to include advocacy interactions and patient-aimed communication materials in close cooperation with the commercial and the Medical Affairs team.

Identify, prioritize and create an integrated global advisory board plan for advisory boards and similar forums for HCPs/Investigators/KOLs in the U.S. and Europe in collaboration with key internal constituents.

May oversee IME/Grants function and Grant Manager responsible for Grant Review Committee (GRC)

Responsible for collaboration across Development teams, Medical, MSLs and Scientific, Research, Product and marketing Teams to ensure the Cooperative Group plans and presence effectively support Onyx research Coop research plans.

Responsible for establishment of a regular and formal communication plan to ensure all appropriate functional groups are informed of status of Scientific Partnership programs such as Advisory Boards, Investigator Forums and Cooperative Group plans.

Conduct business in accordance with Onyx values Other Duties as assigned.

Desired Skills & Experience Work Experience:

Minimum of 5 years experience as a clinician and/or in clinical research. Minimum of 10 years in pharmaceutical industry Experience working directly with the Cooperative Groups/Research networks preferred Experience leading and managing advisory boards or similar forums highly desired Experience with Global and US initiatives as described for a minimum of 2 years highly

desired Medical and Scientific Affairs background as a focus is most relevant prior experience

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Management of Staff: Management of Senior Grant Manager Functional/Technical Knowledge & Skills:

Proficiency with Excel and Power Point for budgeting, strategic planning and communication of departmental initiatives very important

Ability to champion ideas and communicate them clearly; Translate a vision and align multiple functions and levels

Customer & Industry Knowledge:

Knowledge and understanding of relevant clinical and therapeutic issues Ability to create and present on scientific and clinical data Proficient in scientific literature searches, analysis, and evaluation Knowledge on current regulatory and compliance standards

Education/Training: Strong science/clinical background with advanced degree preferred (e.g. MSN,

Pharm.D., Ph.D.) Therapeutic Focus/Experience: Oncology experience is preferred, Hematology

experience highly desirable Existing understanding or relationships in Myeloma, Hematology, and/or Small Cell

Lung Cancer is extremely desirable License/Certification Required: MD, PhD, PharmD preferred Other Requirements:

Strong science and clinical expertise specially in Oncology and/or Hematology Ability to work with little supervision with confidence Ability to handle multiple tasks under hectic, evolving environment Demonstrates ability to drive for results and to support team and corporate success

through technical expertise and broad-based business acumen Demonstrates ability to achieve outcomes through others utilizing a sound collaborative

approach Ability to Integrate functional expertise with business knowledge to develop optimal

solutions for complex problems Demonstrates sound analysis, strategy, decision making, and risk taking skills to

advance the business Demonstrates clear understanding and application of regulatory compliance

requirements Ability to prioritize and plan for development, best practices, and innovation Demonstrated ability to create and facilitate a positive environment by encouraging

leadership, respect, innovation, effective communication, and accountability Excellent interpersonal, leadership, and communication skills Willingness to travel (30-40%), globally and domestically, often on weekends

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:January 28, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals

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Job ID:4494893

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http://www.linkedin.com/jobs?viewJob=&jobId=4891768&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3XbO7pB-ydiBE1

AR&D Associate Director GXP Search, LLC- Orange County, California Area Job Description The primary function for this position is to oversee analytical activities in R&D project group to support the development of niche generic products. This includes development and implementation of standards and methods in R&D Lab, scheduling and supervising group’s daily activities, selecting, developing and evaluating personnel to ensure the efficient operation of the function, supporting ANDA filings and deficiencies responses. Desired Skills & Experience •PhD with 8-10 years of experience in the pharmaceutical analytical chemistry or related sciences, with hands-on knowledge of current analytical techniques, and a proven supervisory experience. • Strong knowledge of FDA/ICH regulations. Company Description Top generic company in Southern CA. contact me for more information about this position..... Additional Information Posted:February 15, 2013 Type:Full-time Experience:Director Functions:Science Industries:Pharmaceuticals Job ID:4891768

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Posted by Everett Bracken, Chairman & CEO, VOLO Careers International - A Global Executive Recruiting Corporation

Senior Commercial Contracts Specialist (Location: Southern California) * Send Resume to RESUME@VOLOCareers.com

************************************************************** For the opportunity below, please send resume to Darshani at wd_darshana at hotmail dot com. Prototype Hardware-Firmware Design Engineer - SF, CA For the opportunity below, please send resume to wd_darshana at hotmail dot com. Various other opportunities are posted in JOBS category at the link below and include - Machine Learning Specialist, DSP Expert, Quality Engineer and more. Prototype Hardware-Firmware Design Engineer - SF, CA There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in

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San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus. Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology. ****************************************************** Apply on company website Healthcare Educator: Northern CA Baxter Healthcare- Sacramento, California (Sacramento, California Area) Job Description We are looking for a bilingual Healthcare Educator based in Northern CA who will be responsible for supporting the sales and marketing efforts by providing bilingual (Spanish) health education to key Baxter accounts. This includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorders communities in No CA, WA and OR General Description 1 Provides support and professional expertise to internal and external customers by providing bilingual (Spanish) health education which includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorder community 2 Conducts outreach and educational programs and serves as a primary Spanish Language (SL) educator and consultant regarding the appropriate use of Baxter products and services to achieve business results 3 Identifies, designs and implements new consulting strategies as dictated by needs of the business and marketplace through collaboration with the sales account team to determine potential opportunities and how to accomplish sales objectives 4 Develop customer partnerships through customer needs analysis and develops strategies to advance SL education for the bleeding disorders community. 5 Mentors new and existing Bilingual Healthcare Educator, Clinical Consultants, Territory Business Managers, and Bleeding Disorders Managers by providing orientation, education and training on new and existing (SL) programs, tools and services and their applications. 6 Provides customer feedback and acts as a consultant to Sales, Marketing and other internal teams on designing and improving new/existing products and customer utilization needs. 7 Coordination/communication of activities and identification of issues across all teams that interface with the customer (i.e. clinical consultants, field service, sales, quality) in order to address issues within assigned responsibilities. 8 Demonstrates compliance with internal procedures, processes and values.

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The ideal candidate will possess the following background: 1 Bachelor's degree preferred, majoring in health care and /or social work arena. 2 Five years minimum experience in health education/social work and patient outreach in the Hispanic community. 3 Strong presentation and communication skills 4 Excellent English and Spanish written and verbal communication skills 5 Hemophilia or bleeding disorders experience preferred 6 Analytical and problem solving capability, along with ability to work independently 7 Ability to develop healthcare educational programs and customer strategies. 8 Strong interpersonal skills and ability to work with team members, customers and internal and external employees at all levels. 9 Travel required 50%, including nights and week-ends. Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V. Additional Information Posted:February 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Health Care Provider Industries:Pharmaceuticals Employer Job ID:58368BR Job ID:4775005 **************************************************** Apply on company website Nurse Educator - San Francisco, CA 4620 Quintiles- San Francisco, US-CA (San Francisco Bay Area) Job Description As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Nurse Educator to join our team of over 10,000 global field personnel supporting our pharmaceutical and biotech clients. Nurse Educator Patients are at the center of our business strategies. The Nurse Educator Program is an educational based program designed as a resource for patients living with auto-immune diseases that have been prescribed specific medications. Nurse Educators provide education about specific disease treatments, and resources to help patients better begin and manage their disease state and resources associated with their prescribed medication. Nurse Educators are responsible for participating in one-on-one communications with patients as well as appropriate medical professionals within the associated treatment process. Since the program is strictly educational based, Nurse Educators do not provide medical advice or work clinically within this role.

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The Nurse Educator will: · Coordinate and facilitate the connection between patients and program approved, patient based resources. · Provide direct educational training to patients on specific disease states, and assigned medication. · Develop local Patient Advocacy opportunities by creating and/or supporting existing community networks and educational forums · Support patient and provider educational speaker programs · Provide patient-focused education to promote behavioral change for the empowerment of patients to improve specific treatment compliance · Foster appropriate dialogue between patient and health care provider Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at: http://www.quintiles.com/ EOE Desired Skills & Experience Job Qualifications:

Bachelor’s degree Preferred BSN and/or RN licensure Current nursing license in good standing 5 + yrs clinical experience in healthcare to include hospital, homehealth ,

pharmaceutical or biotech Nurse educator experience preferred Direct interaction with patient and support for persistence and compliance Knowledge of clinical data and pharmacology Demonstrated time management skills; planning and prioritization skills; ability to

multi-task and maintain prioritization of key projects and deadlines Demonstrated effective presentation skills; ability to motivate others; excellent

interpersonal (written and verbal) skills – with demonstrated effectiveness to work cross-functional and independently

Demonstrated ability to develop, follow and execute developed plans in an independent environment

Demonstrated ability to effectively build positive relationships both internally & externally

Demonstrated ability to be adaptable to changing work environments and responsibilities

Fully competent in MS Office (Word, Excel, PowerPoint) and iPad technology Flexibility to work weekends and eveningAdditional Information

Posted:February 12, 2013 Type:Full-time Experience:Associate Functions:Other Industries:Hospital & Health Care, Medical Practice, Pharmaceuticals Compensation:0 Employer Job ID:1219709 Job ID:4860600

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******************************************************* Apply on company website Healthcare Educator: Northern CA Baxter Healthcare- Sacramento, California (Sacramento, California Area) Job Description We are looking for a bilingual Healthcare Educator based in Northern CA who will be responsible for supporting the sales and marketing efforts by providing bilingual (Spanish) health education to key Baxter accounts. This includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorders communities in No CA, WA and OR General Description 1 Provides support and professional expertise to internal and external customers by providing bilingual (Spanish) health education which includes planning and implementing educational seminars and training programs geared towards the Spanish-speaking bleeding disorder community 2 Conducts outreach and educational programs and serves as a primary Spanish Language (SL) educator and consultant regarding the appropriate use of Baxter products and services to achieve business results 3 Identifies, designs and implements new consulting strategies as dictated by needs of the business and marketplace through collaboration with the sales account team to determine potential opportunities and how to accomplish sales objectives 4 Develop customer partnerships through customer needs analysis and develops strategies to advance SL education for the bleeding disorders community. 5 Mentors new and existing Bilingual Healthcare Educator, Clinical Consultants, Territory Business Managers, and Bleeding Disorders Managers by providing orientation, education and training on new and existing (SL) programs, tools and services and their applications. 6 Provides customer feedback and acts as a consultant to Sales, Marketing and other internal teams on designing and improving new/existing products and customer utilization needs. 7 Coordination/communication of activities and identification of issues across all teams that interface with the customer (i.e. clinical consultants, field service, sales, quality) in order to address issues within assigned responsibilities. 8 Demonstrates compliance with internal procedures, processes and values. The ideal candidate will possess the following background: 1 Bachelor's degree preferred, majoring in health care and /or social work arena. 2 Five years minimum experience in health education/social work and patient outreach in the Hispanic community. 3 Strong presentation and communication skills 4 Excellent English and Spanish written and verbal communication skills 5 Hemophilia or bleeding disorders experience preferred 6 Analytical and problem solving capability, along with ability to work independently 7 Ability to develop healthcare educational programs and customer strategies. 8 Strong interpersonal skills and ability to work with team members, customers and internal and external employees at all levels. 9 Travel required 50%, including nights and week-ends. Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.Additional Information Posted:February 1, 2013 Type:Full-time

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Experience:Mid-Senior level Functions:Health Care Provider Industries:Pharmaceuticals Employer Job ID:58368BR Job ID:4775005 ****************************************************** Started by Jon Hauptman, President, The Hauptman Group Healthcare Search Consultants APPLY DIRECT to www.thehauptmangroup.com Hospital Sales Rep - (Transplant) - San Francisco! Strong pharmaceutical sales organization is looking for a proven "top performer" with a documented track record of success within the Hospital setting. Candidate "MUST" have injectable experience. Transplant experience is a plus. Total Compensation $130k - $160k Salary, Uncapped Bonus! Company Car, Medical, Dental, GREAT 401k, Outstanding Package! MUST HAVE Qualifications: 4-Year Degree; 3 Years Pharma Sales with Current Hospital Sales Experience; Consistently Ranked within the Top 20% in the Nation; Injectables Experience Transplant experience helpful! Must have Strong Documentation and be HIGHLY Decorated with Documented Track Record of Exceeding Quota Top Performers, only - No job hoppers! ________________________________________________________ Specialty Pharma Rep (Pain) - San Jose! APPLY DIRECT to www.thehauptmangroup.com STRONG specialty pharmaceutical organization is looking for a proven "go-getter" who has a consistent track record of success within the pain management (pharma) arena. Must Have QUALIFICATIONS: 4-Year Degree 3+ Yrs Pharma Sales Relationships w/ Pain Management and/or Orthopedics preferred Decorated with Documented Track Record of Exceeding Sales Quota Top Performers, only! No job hoppers. Salary + Bonus : $100k - $130k Great Benefits: Car, Medical, Dental, GREAT 401k, etc.. **************************************************** Posted by Amanda Rosales, Recruiter at SMR Group Ltd Email resume to alan@smrgroupltd.com

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Looking for specialty pharma reps w/ demonstrable over quota sales success in San Francisco, CA, Cincinnati, OH, Atlanta East, GA, Los Angeles, CA, Towson, MD, Boston, MA, Knoxville, TN ___________________________________________________ Looking for specialty pharma reps w/ demonstrable over quota sales success in San Jose, CA, McAllen, TX, Hempstead-Melville, NY, Fargo, ND, New York, NY, Albany, GA, Lima, OH, Phoenix, AZ Email resume to alan@smrgroupltd.com __________________________________________________ Looking for specialty pharma reps w/ demonstrable over quota sales success in Sacramento, CA, Arlington, VA, Denver, CO, El-Paso-Albuquerque, TX-NM, Morristown, NJ, Boise, ID, Newtown, PA, Miami, FL Email resume to alan@smrgroupltd.com _____________________________________________________________ Looking for primary care reps w/ demonstrable over quota sales success in South Bend, IN, Norwich, CT & Orange, CA. Email resume to alan@smrgroupltd.com ******************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-California-Biotechnology-Jobs-Careers-74698 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Clinical Research Associate / CRA Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Monitor one or more clinical trials 2) Participate in the design and writing of protocols, case report forms and informed consent forms for all clinical trials 3) Initiate and coordinate study start-up activities, including investigator identification and selection, contract and budget preparation, presentation at investigator meeting and vendor/investigator training 4) Take responsible for study management, including CRO, central lab and vendor management 5) Collect documents and generate supplemental material, including monitoring plans, data management plans and training materials 6) Ensure site evaluations, investigator meetings, study initiation, monitoring, closeout visits, review of case report forms, adverse event recording and reporting 7) Manage and ensure that the studies are conducted and adhere to FDA/ICH guidance on Good Clinical Practices (GCP) 8) Monitor investigator performance and ensure protocol compliance and patient safety 9) Ensure that Case Report Forms (CRFs) are reviewed, pulled in a timely manner and submitted to Data Management 10) Assist in writing and compilation of the clinical report for submission 11) Coordinate clinical supply requirements, shipping and key documentation with global R&D locations TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech,

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Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151174698 Job ID:4935151 _____________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-84415 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Regulatory Affairs Associate / RA Associate Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Assist in reviewing and maintaining documentation associated with manufacturing and

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vendor qualifications 2) Coordinate and support the development of the finished product stability program 3) Assist in maintaining the R&D database 4) Represent R&D by offering technical assistance to multiple groups within the company, including quality control 5) Oversee regulations, research and current events in regards to product labels, product claims and nutritional values, and material issues 6) Maintain up-to-date knowledge of laws, regulations and policies enforced by the federal, and the state governments 7) Author submissions and other regulatory documents to obtain approval to bring new or modified products to market TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151184415 Job ID:4935128

2/24/2013 16

______________________________________________________ To apply, please use this link http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-R-AND-D-Science-California-Biotechnology-Jobs-Careers-86977 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Associate Director of Clinical Pharmacology Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Develop and maintain program specific and comprehensive clinical pharmacology strategic development plan 2) Prepare clinical pharmacology sections of regulatory documents and represent clinical pharmacology during interactions with regulatory agencies 3) Assist with co-ordination of key opinion leaders, consultants and other therapeutic area specialists in the drug development process 4) Participate in the drafting and finalization of clinical study protocols and study analysis plan (SAP) 5) Provide clinical pharmacology/pharmacokinetic subject matter expertise to the clinical study team/joint development team 6) Conduct pharmacokinetic analysis 7) Prepare external presentations and publication TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted.

2/24/2013 17

Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Director Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151186977 Job ID:4935097 ________________________________________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Quality-R-AND-D-Science-Laboratory-California-Biotechnology-Jobs-Careers-87456 or you can email resume to: resumes@sterlinglifesciences.com (NO PDFs please - we prefer MS-WORD or plain text) Sales Account Manager, Lab equipment ( Business Development ) Sterling Life Sciences- California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Grow new accounts, identify new opportunities and build relationships to gain new business revenue for the company 2) Implement effective sales plans to position the organization competitively and meet / exceed territory objectives 3) Identify the needs of new prospects and develop appropriate responses 4) Perform field calls for the account and assigned territory 5) Participate and attend sales meetings and professional association meetings outside of regular business hours, as required 6) Build and maintain key alliances with distributors and field sales team 7) Communicate with all levels of management within both the distributor and field sales organization TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description

2/24/2013 18

Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). You are also welcome to join his network on LinkedIn: amehta@sterlinghoffman.net - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151187456 Job ID:4935088 ************************************* Apply on company website Account Executive Veeva Systems- San Diego metro (Greater San Diego Area) Job Description Veeva Systems is looking for experienced Account Executives to drive sales for cloud-based solutions including CRM and Content Management applications into major life science organizations. As an Account Executive, you will be responsible for generating qualified opportunities, winning new business and managing relationships with large customers. Creativity, energy and the ability to work effectively within a growing team are critical. Qualified applicants should be in the United States in the MidAtlantic or Southern California. Ideal locations are in a metro area of New Jersey or Southern Cal / San Diego metro. Responsibilities:

Understand and present the Veeva products and inspire prospect interest Manage relationships with key stakeholders across business, IT, and C level Meet/exceed pipeline generation and revenue targets Manage complex sales cycles, utilizing internal and external resources as appropriate Be willing to travel

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Desired Skills & Experience Requirements:

5-7 years experience selling enterprise software and related services into complex environments

Proven track record of meeting and exceeding sales quotas Experience selling into Top 30 Pharma/BioTech companies Strategic account planning and execution skills Must be highly self-motivated and able to work with little direct supervision Excellent oral and written communication skills A passion for solving people’s business problems 4 year degree required

Nice to Have: Strong understanding of content management challenges and CRM value in the life

sciences industry is desired. Company Description Veeva Systems is the leader in cloud-based business solutions for the global life sciences industry. Committed to innovation, product excellence and customer success, Veeva has over 150 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is a privately held company headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Budapest, Paris, Beijing, Shanghai and Tokyo. For more information, visit www.veevasystems.com. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales Industries:Computer Software, Pharmaceuticals Job ID:4950574 ***************************************************** Posted by Isabel Brito, Atlantic Management Resources Send resumes to ibrito@amrjobs.com We are looking for dedicated hospital sales reps in San Francisco or Sacramento We are looking for dedicated hospital sales reps in San Francisco or Sacramento who have 3+ years of top-performing hospital experience. Awesome opportunity to work for a small, growing specialty pharma company with plenty of room for upward mobility.

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http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=216743176&gid=61852&trk=eml-anet_dig-b_jb-ttl-cn&ut=2fSwJXsWxQi5E1

Posted by Allison Glogovac, Clinical & Scientific Recruiter at Bayside Solutions

Actively looking for a STAT PROGRAMMER for my Bay Area Client! ******************************************************** Apply on company website

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Director, Scientific Partnerships (US/ROW, New Txs, New Geography, New Products) Onyx Pharmaceuticals- Corporate Office - South San Francisco (San Francisco Bay Area) Job Description Summary The Director of Scientific Partnerships is responsible for global (US, EU and ROW) strategic initiatives with HCPs/investigators/thought leaders to include engagement plans, congress planning for KOL engagements, advisory boards and Investigator Forums. He/she will partner with corporate communication as a medical resource to the external advocacy groups and for associated activities. The candidate will act as a liaison to clinical and medical organizations to support the strategy including significant academic institutions, large community research sites and research cooperatives. The function may oversee IME/Grants that supports overall scientific strategy & communication. Essential/Primary Duties, Functions and Responsibilities Engage global thought leaders to develop advocacy, awareness, education and research for Onyx proteasome inhibitors (PIs) in current and emerging indications/disease states, new geographies and new products. (US/ROW (as defined as non EU new geographies – New tumors/indications, new products) Lead KOL Strategy to include a strategic plan, identification/profiling, individual engagement plans, congress KOL sub team and implementation of coordinated KOL engagements (Asia Pac, Americas/Canada, and expansion geographies)

Differentiate Onyx PIs as the preferred proteasome inhibitors and establish Onyx as the scientific partner of choice through innovative initiatives, coordinated strategy and scientific communication

Develop and oversee innovative programs that meet scientific interests for KOLs/investigators/key customers and Onyx (i.e. Visiting Professor Days to Onyx, INTERSECT program for Onyx to visit key centers, Global Investigator Forums in ROW or maybe EU, PRISM NTP (Novel Therapies Program) a global research collaboration to combine pipeline with novel compounds)

Create and integrate plans for cooperative groups and research networks in the US, Europe and in expansion geographies

Partner with Advocacy to develop strategic and tactical plan to include advocacy interactions and patient-aimed communication materials in close cooperation with the commercial and the Medical Affairs team.

Identify, prioritize and create an integrated global advisory board plan for advisory boards and similar forums for HCPs/Investigators/KOLs in the U.S. and Europe in collaboration with key internal constituents.

May oversee IME/Grants function and Grant Manager responsible for Grant Review Committee (GRC)

Responsible for collaboration across Development teams, Medical, MSLs and Scientific, Research, Product and marketing Teams to ensure the Cooperative Group plans and presence effectively support Onyx research Coop research plans.

Responsible for establishment of a regular and formal communication plan to ensure all appropriate functional groups are informed of status of Scientific Partnership programs such as Advisory Boards, Investigator Forums and Cooperative Group plans.

Conduct business in accordance with Onyx values Other Duties as assigned.

Desired Skills & Experience Work Experience:

Minimum of 5 years experience as a clinician and/or in clinical research. Minimum of 10 years in pharmaceutical industry

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Experience working directly with the Cooperative Groups/Research networks preferred Experience leading and managing advisory boards or similar forums highly desired Experience with Global and US initiatives as described for a minimum of 2 years highly

desired Medical and Scientific Affairs background as a focus is most relevant prior experience

Management of Staff: Management of Senior Grant Manager Functional/Technical Knowledge & Skills:

Proficiency with Excel and Power Point for budgeting, strategic planning and communication of departmental initiatives very important

Ability to champion ideas and communicate them clearly; Translate a vision and align multiple functions and levels

Customer & Industry Knowledge:

Knowledge and understanding of relevant clinical and therapeutic issues Ability to create and present on scientific and clinical data Proficient in scientific literature searches, analysis, and evaluation Knowledge on current regulatory and compliance standards

Education/Training: Strong science/clinical background with advanced degree preferred (e.g. MSN,

Pharm.D., Ph.D.) Therapeutic Focus/Experience: Oncology experience is preferred, Hematology

experience highly desirable Existing understanding or relationships in Myeloma, Hematology, and/or Small Cell

Lung Cancer is extremely desirable License/Certification Required: MD, PhD, PharmD preferred Other Requirements:

Strong science and clinical expertise specially in Oncology and/or Hematology Ability to work with little supervision with confidence Ability to handle multiple tasks under hectic, evolving environment Demonstrates ability to drive for results and to support team and corporate success

through technical expertise and broad-based business acumen Demonstrates ability to achieve outcomes through others utilizing a sound collaborative

approach Ability to Integrate functional expertise with business knowledge to develop optimal

solutions for complex problems Demonstrates sound analysis, strategy, decision making, and risk taking skills to

advance the business Demonstrates clear understanding and application of regulatory compliance

requirements Ability to prioritize and plan for development, best practices, and innovation Demonstrated ability to create and facilitate a positive environment by encouraging

leadership, respect, innovation, effective communication, and accountability Excellent interpersonal, leadership, and communication skills Willingness to travel (30-40%), globally and domestically, often on weekends

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information

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Posted:January 28, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Job ID:4494893 ******************************************************* To apply: Visit http://tinyurl.com/atswglj or www.BMRN.com CMC Project Manager (Clinical Product Lead) BioMarin- San Francisco Bay Area Job Description Job Description: The CMC Project Manager (Clinical Project Lead) will act as the single point person or single repository that tracks the many CMC-related activities on a product-by-product basis for several clinical product programs. The CMC Project Manager will track projects consistently and in detail using standard PMBOK practices and those project management practices associated with the BioMarin TPMG group .The CMC Project Manager will plan for the Technical Operations related activities, manage and track key clinical CMC activities, including identifying responsible individuals for completing; anticipate, resolve, and escalate issues; coordinate CMC plans with global development and forecasted commercialization plans and contribute to the development of a product portfolio view within Technical Operations. Job Responsibilities and Duties (including skill set needed/requirements):

Plan/manage/track key CMC activities, including identifying responsible individuals o DS, DP, API labeling/packaging o Regulatory submissions – including the tracking of INDs (and the comparable

filings on a country-by-country basis) approved in particular countries and the timing for introduction of clinical products

o Facility, equipment, IT systems requirements – in cases where implementation impacts specific product timelines

o Global distribution plans o Partner commitments, as appropriate o Contractor status – including the tracking-to-closure of CMO deviations

Develop a consistent methodology for managing CMC Subteams o Roles/responsibilities for team members, including defining appropriate

membership o Define decision-making authority for team and when to escalate o Consistent meeting management: agendas, desired outcomes, read-ahead

documents, minutes, etc. o Consistent use of project tracking tools (e.g., Primavera, MS Project,

dashboards, etc.) Anticipate, resolve, escalate issues as appropriate

o Scheduling conflicts o Technical issues o Processing issues o Compliance issues o Resource issues o Facility and equipment issues

Coordinate CMC project plans with global company plans o Galli and Shanbally production plans o Contract manufacturing production plans o Clinical development plans o CMC regulatory filings meeting

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o Assist with tracking project costs to be consistent with company budget Coordinate CMC project plans with the other Portfolio Leaders

o Clinical Product Lead o Commercial Product Lead o Portfolio Controllers and Master Controller

Develop a portfolio view of TOPS activities across clinical product programs along with other TOPS Product Leads and led by the head of TOPS Program Management.

o Allows for prioritization discussions across projects EEO/M/F/D/V Desired Skills & Experience Skill set required:

5+ years of experience with managing clinical pharmaceutical products from a project management, product development, process development and supply chain perspective.

5+ years experience within a Pharmaceutical Technical Operations group is required. Prior experience at building and developing schedules for CMC groups a must. A demonstrated ability to manage portfolio and project budgets A demonstrated ability to develop resource loaded and leveled plans A demonstrated ability of facilitating large cross-functional meetings within a

pharmaceutical setting is a must. Excellent interpersonal skills, including clear, succinct and timely communication and

proven ability to foster important relationships with customers and key stakeholders. The integrity and accuracy of project information to meet management requirements Partnering with the head of the Planning Management group in identifying, managing &

communicating key project risks and leading risk management strategies Working knowledge of project management practices either from a formal PMO

background or from extensive experience in managing projects or programs Bachelors Degree in a scientific discipline required. Advanced degree in science or

business preferred. - Project Management certification or equivalent is a plus (i.e.: PMP or equivalent Experience with Risk management practices an advantage).

Strong influence, negotiation, analytical and presentation skills. Ability to work effectively with cross-functional teams Ability to work in a highly matrixed organization with strong influence management

skills Extensive experience with MS Project or PrimaVera is a must. Extensive experience with Microsoft Office package, especially Excel and PowerPoint is

preferred. To apply: Visit http://tinyurl.com/atswglj or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is

2/24/2013 24

currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. Additional Information Posted:February 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Strategy/Planning Industries:Biotechnology Job ID:4917543 ___________________________________________________________ Automation Engineer 1 – 2 To apply: Visit http://tinyurl.com/aw9ml7m or www.BMRN.com BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY • Final position offered will depend upon experience level of selected candidate. • Support existing control systems utilized in manufacturing operations, as well as support the design, engineering, and commissioning of new control systems. o Responsible for troubleshooting and problem-solving of manufacturing operations control systems/automation/instrumentation issues. This will include new installations, as well as replacement or upgrading of existing systems. o The position will require working closely with Facilities and manufacturing project managers (as part of project teams) to accomplish construction/installation. o This position will also require the development and implementation of system commissioning plans and interact with Validation on the qualification of these systems. • This position will require working with validated and non-validated systems. Modifications to validated system will require working within the Change Control program. RESPONSIBILITIES • Troubleshooting and problem-solving of existing manufacturing operations control systems/automation/instrumentation issues. Diagnose technical issues and provide recommendations/solutions for corrective actions. Follow established Quality Control systems. Review changes and assure appropriate documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans) are developed and on file. • Execute medium to high-level control systems projects/assignments in the support of site operations through investigations, control system assessments, and design support. Proactively look for and recommend improvements in site processes and procedures. • Working under direction of senior engineers, review, specify, design and/or install process control systems in direct support of commercial and clinical manufacturing operations. Create or review appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans, IQ/OQ). • Support and/or execute acceptance testing and IOQ protocols. • Maintain a library for vendor application software, historical data storage, back-up custom software applications, and required hardware needed for troubleshooting and maintenance. • Maintain support for building management systems (BMS) and other plant automation, including the design, implementation, and documentation of system changes. Interface with QA Validation group for GMP systems. • Assist with troubleshooting complex control system problems. Assure integrity of equipment operation as the result of troubleshooting or repair. Desired Skills & Experience EDUCATION

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• BS or MS Chemical, Electrical, or Mechanical Engineering from an accredited university. EXPERIENCE • Experience in PLC and data acquisition systems, building management systems (BMS), distributed control systems (DCS), mechanical operation of equipment, and process control are essential. • Experience with developing GAMP controls documentation for internal projects as well as reviewing/approving vendor supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans). • Allen-Bradley PLC hardware and software experience preferred (SLC, CompactLogix, ControlLogix, RSLogix500, RSLogix5000, and DeviceNet). • Experience with networks and communication protocols preferred. • Intellution iFix 4.5 SCADA experience preferred. • Intellution iBatch experience preferred. • DeltaV experience preferred. • Pi Historian experience preferred. • Virtual Machines experience preferred. • Strong organization, interpersonal, oral and written communication skills. • Minimum of 3 years experience with the installation, startup, and servicing of process control systems. • Minimum of 3 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment. • Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities strongly preferred. • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Access. To apply: Visit http://tinyurl.com/aw9ml7m or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. Additional Information Posted:February 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering Industries:Biotechnology Job ID:4917490

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********************************************************* ******************************************************** Apply on company website Director/Senior Director Marketing Medivation- San Francisco, Ca (San Francisco Bay Area) Job Description The Director/Senior Director of Marketing will lead the marketing team of Medivation’s first marketed product. This position reports to the VP of Marketing and will have at least 2 direct reports. This position offers the opportunity to join a team early in the evolution of product life cycle with a fully accrued Phase 3 study for the next indication ongoing. You will be a key contributor to the team in leading both strategic and tactical aspects of the promotional activities including advertising and promotional tactics, lifecycle management, PR, sales force communication and other brand marketing activities. This position must demonstrate an appreciation for strategic marketing with innovative approaches with a track record of success, as well as boundless energy and initiative. This role will require the ability to thrive in an environment of rapid change; a proven ability to work effectively within cross-functional teams as both a leader and a participant; will be highly innovative and creative as well as have the ability to inspire creativity and innovation in their team; and have a passion for science based brands that can dramatically improve patients' lives. Frequent exposure to high level executives both within Medivation and our partner company is expected so excellent communication skills and sound judgment are critical skills for success. This product is partnered with Astellas Pharma, Inc., a Japanese company with US headquarters near Chicago, IL. This position will have extensive contact with our partner company and maintaining our excellent relationship is a must. Desired Skills & Experience Essential duties & responsibilities but not limited to the following:

Good understanding of drug development/life-cycle management to help maximize the value of the product over the IP lifespan

Drive the integrated strategic and tactical commercial plans across a broad range of customer segments (health care provider, payer and patient) and markets (North America) to ensure an optimal and successful product launch.

Lead health care provider campaign including core visual aid, journal advertisement, educational leave-behinds, etc. whether in traditional or digital format

Provide regular executive management updates of promotion progress Responsible for utilizing primary and secondary market research to shape direction of

promotion, develop annual market research plan in partnership with market research team

Lead, motivate and develop direct reports Be known as a thoughtful, collaborative partner with Astellas. Anticipate and head off

problems caused by inefficient communications. Alert stakeholders internally to any potential issues or roadblocks that may jeopardize success of the product.

Perform all company business in accordance with regulations (e.g. EEO, FDA, OSHA, PDMA, EPA, PhRMA, etc.) and company policies and procedures, immediately reporting all noted/observed violations to management.

Requirements: Bachelor’s degree required. Graduate degree a plus. A successful track record with brand management, marketing team leadership, and

talent management Demonstrated expertise in marketing to diverse customer segments including

physicians, payers and consumers. Specialty markets experience a must.

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Documented experience in overseeing lifecycle management and market development/expansion activities

An understanding of the global reimbursement environment and drivers for value based access with a focus on the U.S.

Proven ability to successfully lead/work in a cross functional team setting (clinical, medical affairs, sales, managed markets, regulatory, legal, R&D, project management)

Demonstrates high ethical and professional standards with business contacts in order to maintain Medivation’s excellent reputation within the biotech community

Excellent communication and presentation skills, strong business acumen, analytical orientation, and ability to influence others

Demonstrated ability to create financial and operational objectives across business departments

Experience with a co-development or co-promotion product is a plus Ability to accommodate ~30% travel

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V Company Description Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publically traded biopharmaceutical company located in San Francisco. Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation’s goal is to transform the treatment of these diseases and offer hope to critically ill patients and their families. With the approval of Xtandi (enzalutamide) capsules in late August and the early September product launch immediately following, Medivation is in the process of building and developing a world-class workforce to take the company to the next strategic level. Additional Information Posted:February 4, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Pharmaceuticals Job ID:4787051 ****************************************************** Posted by Tim Flynn, PRC, CDR, CIR, ACIR, CSSR, Amgen Staffing Client Services Manager through The RightThing, Inc. an ADP Company Hiring - Regulatory Affairs Professionals - Southern San Francisco Apply Here - http://jobvite.com/m?34VtIfwU Join Onyx Pharmaceuticalshire.jobvite.com We're hiring for Associate Director, Regulatory Affairs - Emerging Markets, Director/Senior Director, Global Regulatory Lead, Associate Director/Director, Regulatory Affairs, Associate Director, Regulatory Affairs, Labeling,... ****************************************************** https://jobs.smartbrief.com/action/listing?listingid=463F74FC-A105-459E-BCEC-3825DF9093F6&briefid=263a5f36-6763-46c7-b399-

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4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/8/13 Location: Irvine, CA Salary Range: Open Years Experience: 10 Director of Global Infrastructure - 002196 Edwards Lifesciences Job Description Leadership: * Achieve excellence in defining, developing and deploying business-centric IT solutions * Champion change and effectively manage the implementation of new ideas * Provide leadership and management over the Irvine Infrastructure team * Provide leadership and support for regional IT resources * Promote the company through attendance and speaking engagements at industry conferences or involvement in local business organizations Departmental Management: * Define, develop, present to management, gain acceptance and approval of ITLT or CIO a plan that is aligned and coherent with an overall Global IT strategy plan * Lead global implementations, and provide technical oversight to regional IT projects to ensure they are in-line with global standards * Work with RMs, stakeholders and regional IT resources to assess and respond to day-to-day business IT needs * Hold regular departmental meetings to review strategic goals and initiatives, promote teambuilding and work to provide growth paths for staff * Supervise the ongoing operations of the Desk Top Support providing quality and timely support to Edwards employees concerning hardware and software needs * Lead recruiting, hiring, on-boarding and training for IT support staff * Administer the department budget * Defines and enforces standard company policies and procedures as it relates to Global Infrastructure * Serve on planning and policy-making committees as required Teamwork: * Reinforce team approach to problem resolution, especially as it pertains to working with the global IT team * Support and solicit input from team members at all levels within the organization Client Management: * Communicate effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, with always an eye toward a single, global solution * Continually define ways to increase internal client satisfaction and deepen client relationships * Provide senior level resolution to internal and external client issues Infrastructure and Desktop solutions (Hardware and Software): * Establish global infrastructure and application solution standards * Identify emerging information technologies to be assimilated, integrated, and introduced within the regional infrastructure fabric * Oversee the commissioning of infrastructure to ensure that it is harmonized with global standards, so that Edwards employees always have the same experience, “anywhere, anytime” * Oversee the testing, selection and implementation of new desktop solutions and changes to existing solutions that are (1) global in nature; and (2) localized just enough to meet the statutory and regulatory requirements in the region * Serve as primary contact with outside vendors in the generation of RFPs, bids, contracts, agreements, and other major vendor interactions Systems Operations and Maintenance: * Oversee the integrity and continual operation of the global network, including LAN/WAN and data center services * Ensure the continual functioning of mission critical infrastructure, application solutions and operations * Maintain security and privacy of the information systems, communication lines, and equipment * Define, develop, review, and certify all back-up and disaster recovery procedures and plans * Oversee IT related aspects of all the regional construction and renovation projects

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Education, Skills and Abilities: * B.S. degree in computer science, computer engineering, electrical engineering or related field, a Master’s degree is a plus * Ten years management/leadership experience, including deployment and management of global infrastructure an on a large scale * Experience moving or building a data center is highly preferred * Strong analytical and logical problem solving skills * Strong interpersonal communication and relational skills * Proven organizational and project management skills, working in a satellite location of a multi-national corporation, preferably US-based * User-centered attitude and willing to work in a team oriented environment that serves a diverse population * At ease in a matrix organization * Speaks English as a first language * Possess and displays sound judgment; initiative; flexibility and detail-orientation ********************************************************** For Further information and to apply please Call Tom Doyle at kppm in Dublin on: 01-2932220 or Email: tom@kppm.ie Process Engineers (For roles in San Diego USA) Process Engineers (For roles in San Diago USA) 1 x Senior Process Engineer (10+year's experience) and 1 x Intermediate Process Engineer (5+Year's Experience) Degree Qualified with strong Process Design Experience on Sterile Manufacturing Plants. This is to work within a Design Team working on Large and small plant expansion projects candidates who also have Installation through to Commissioning and Handover stage would have a distinct advantage. These are long term contract positions with excellent all-inclusive hourly rates and Return Flight packages. ******************************************************** Posted by Joanna Seidler Farber, ★ IT & Pharmaceutical Staffing/Recruiting (& Publishing Pro!) ★ Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindip@alphaconsulting.com *** HIRING *** Alpha Consulting Corp. is seeking a MANAGER / ASSOCIATE DIRECTOR, CLINICAL PHARMACOLOGY [ONCOLOGY] for its client to work in SAN DIEGO, CA *** W-2 CANDIDATES ONLY *** (13-00134) REQUIREMENT #13-00134 RECRUITER: CINDI PISNOY JOB LOCATION: SAN DIEGO, CA *** W-2 CANDIDATES ONLY! *** Project Description: Integrate drug metabolism, biopharmaceutics, and toxicology data to design clinical pharmacology study protocols for oncology compounds. Support a full development compound, design and writing clinical pharmacology study protocols, analysis plans and clinical reports, IBs, etc., and oversee clinical pharmacology aspects of clinical studies. Use standard PK software (eNCA and NonMem) to integrate PK and clinical data (PD) to evaluate optimal doses/regimens, analyze study results, draft Clin Pharm or clinical reports and provide quality control of analyses. Evaluate and apply new clinical data and data analyses to refine studies in development plan. Actively participate within the group to assist in meeting timelines by providing the requested data analyses, and work closely with the Clinical Pharmacology Team Leader in charge of the program. Responsibilities: • Design and implement a clinical pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates is rapidly

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achieved in the U.S., EU, Asia and throughout the world • Design and conduct clinical pharmacology studies such as drug-drug interaction, special population, and bioequivalence studies • Design dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients • Summarize and interpret results of clinical pharmacology studies and pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs • Use innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosing regimens, and study designs throughout clinical drug development • Evaluate and apply new techniques in PK/PD data analysis that improve information quality and utility, and enhance productivity • Design study protocols, analyze PK/PD data, and interpret results to meet the objectives of the Clinical Pharmacology Plan • Provide expertise to the Asset Team and the Clinical Sub-Team to optimize dose, dosing regimen, study designs, and strategy based on exposure-response information • Plan and direct clinical pharmacology components of clinical programs and studies • Lead multifunctional study team to design, deliver, and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies. Conduct regulatory-level non-compartmental analysis on data and takes scientific lead on clinical study report contribution • Deliver a drug interaction plan based on pharmacokinetic (e.g. metabolism, transporters) and pharmacodynamic properties of the candidate, as well as the medical/commercial needs • Summarize results of PK/PD analyses in Clinical Study Reports (CSR) and publish in peer-reviewed journals Qualifications: • Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, or related discipline • 4-8 years of postgraduate experience in clinical pharmacology, pharmacokinetic, and/or pharmacodynamic research in industrial setting • Clinical drug development, oncology drug development, and proven record of leadership Technical Skill Requirements: • Demonstrates thorough understanding of the following: 1) principles of PK, PK/PD 2) data analysis using non-compartmental and model-based PK and PK/PD methods 3) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology, and therapeutics especially oncology This PERMANENT position starts ASAP. ************************************************** Interested candidates can contact Nancy Symonds for more information (njs@nancysymonds.com). QUALITY CONTROL DIRECTOR - S. CALIFORNIA This position is located in Orange County and will have oversight for 25 staff, 4 direct reports. We are looking for strong management/leadership skills and expertise in analytical methods development. Must have biologics experience. Will report to VP Quality.Relocation assistance provided. Will relo nationwide. Your referrals are appreciated.

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Summary Responsible for the overseeing the Analytical Methods, Quality Control, Stability and Microbiology functions ensuring the manufacture and release of quality products and conformance to regulatory guidelines. Essential Duties and Responsibilities include the following. Other duties may be assigned. Quality Control Responsibilities: • Provide leadership to oversee and assure the activities of quality control systems, and laboratories in all areas are efficient, effective for internal and external customers and within the highest conformance to regulatory guidelines • Make recommendations for process improvement and corrective action to assure that the operations are ready for future manufacturing and customer projects. • Manage timelines and resources effectively to meet client and internal timelines with resources available. • Familiar with SOPs, Test Methods and validation protocols and has the knowledge to write and execute new developmental activities. Use of technical proficiency, scientific creativity, independent thought and collaboration with others to solve bioanalytical assay related problems. • Collaborate with Company's personnel/departments in order to meet internal/external customer requirements. • Assist with several other Quality System functions in order to maintain Good Manufacturing Practice (GMP). Supervisory Responsibilities Manage/direct the selection, training, motivation, development, appraisal and work assignments for QC personnel. Oversee a staff of approximately 20-25 QC technicians and 4 QC Managers. Education and/or Experience BS in Biochemisty, Chemistry, or related science with a minimum of 10 years related experience, training; or equivalent combination of education and experience. Experience with biologics products is required, preferably derived from mammalian cell culture. Must have experience supervising/managing QC functions in a cGMP environment. Must have knowledge of cGMPs, 21CFR210-211, ISO 14644, Federal Std 209-E. Experience in writing and executing IQ, OQ, PQ required. Experience in Regulatory Compliance Inspections required. Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines required. **************************************************************** Posted by Tim Flynn, PRC, CDR, CIR, ACIR, CSSR, Amgen Staffing Client Services Manager through The RightThing, Inc. an ADP Company Hiring for Sr Biopharmaceutical Rep, Oncology - Pasadena, CA at Pasadena -California and is looking for suitable candidates. I am using wisestep.com to share my jobs on Multiple Linkedin Groups with a single click. Apply Online http://www.wisestep.com/RSFTYWTX/IRIGKORRQR or Refer Friends who will love to take it. Job Description: Territory#18623 Pasadena, CA covering , CA: West to Burbank, East to Loma Linda, South to downtown Los Angeles, North to BakersfieldAs a Sr Biopharmaceutical Representative, you will act as the primary customer contact for demand creation by executing

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marketing strategy and promoting Amgen products as lead by the District Manager. In this strategic role you will provide current and comprehensive clinical knowledge of Amgens products and effectively communicate the clinical and economic benefits of the products. As a sales leader you are expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets. Sr Biopharmaceutical Representatives are also responsible for servicing and managing accounts, which includes ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts. Additional responsibilities involve providing feedback on marketing strategy and effectiveness reviews of sales activities and territory analysis, in addition to developing territory plans with your District Manager Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline Basic Qualifications Bachelors degree & 2 years of sales experience OR Associates degree & 6 years of sales experience OR High school diploma / GED & 8 years of sales experience Preferred Qualifications Two or more years of sales and/or marketing experience within pharmaceutical, biotech, healthcare, or medical device industries Product or hospital sales experience in the areas of oncology, nephrology, dermatology, rheumatology and inflammation is highly preferred Neurology, endocrinology, hepatology, gastroenterology, or infectious diseases, and the diseases and treatments involved with these specialties is also highly preferred Local Market knowledge A Bachelors degree in Life Sciences or Business Administration Core Competencies: Planning and Organizing Work Engaging Others Through Effective Communication Drive to Achieve Individual Leadership and Impact ******************************************************* Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Project Coordinator Now hiring: Clinical Project Coordinator http://www.ziprecruiter.com/job/Clinical-Project-Coordinator/d6c54142/?source=social-linkedin-group-jobs ****************************************************** Posted by Elizabeth Rountree, Biotech Consultant Please send your cover letter/resumes to: sfresumes@c1consulting.com Manager Position at C1 Consulting (San Francisco) C1 Consulting is seeking an experienced Manager (7+ years of relevant experience) for the San Francisco office. C1 stands for "Customer's First" and successful candidates for this position are passionate about problem solving and enjoy working directly with clients to meet their business objectives. The position has four core components: 1) Client Management: Manage the client relationship for one or more clients. This aspect of the role includes business development/generating new projects as well as management of sold projects to ensure high client satisfaction. 2) Project Leadership: The Manager will be expected to be a "hands on" member of each project team and provide direction to ensure that the project meets client needs and business objectives, that the design, analysis, and deliverables are of the highest quality, and that team members have a clear understanding of their roles and responsibilities. Most Managers at C1 are also involved in moderating qualitative interviews (with our customers, Key Opinion Leaders, physicians, patients, and other stakeholders) on consulting and market research

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projects. Travel to client meetings, conferences, and market research is common - though much less than in traditional management consulting. 3) People Management: This position will have multiple direct reports and will be actively involved in staff professional development and mentoring. As a small firm, C1 relies heavily on on-the-job learning. Managers work closely with their direct reports to provide training and advice on client projects, develop professional development goals, provide career guidance, and evaluate performance. 4) Company Development: C1 is a small, dynamic consulting firm and each C1 team member has a role in making our company stronger. This position will be responsible for leading an important strategic initiative which may be internally focused or externally focused, depending on skills and interests. C1 projects are most often staffed with two to four team members. Working with small teams creates a close working relationship with other C1 team members and clients. Direct involvement of all team members with clients enables a better understanding of their needs and how project results and insights get used. C1 is a dynamic and growing company. The Manager position offers significant opportunity for growth. Desired Profile Ideal candidates for the position are graduates of top Masters or PhD programs with a minimum of 7 years of relevant work experience in pharmaceutical/biotechnology marketing, market research, or consulting. Candidates with more experience (12+ years) may be considered for a Director position. Candidates must have a strong analytic background and possess a clear understanding of the drug and/or medical device and/or diagnostic commercialization, forecasting, marketing and sales processes, and also have the ability to recommend creative methods to address clients’ objectives, interpret complex data, and draw key implications from results. In addition to strong educational background and work experience, we evaluate the following qualities when reviewing Manager candidates: • Passion for problem solving • Attention to detail • Exceptional work ethic • Good communication skills • Effective working in teams • Strong leadership Permanent U.S. Employment Authorization required. ******************************************************** Posted by Giovanni Lauricella, Medical Device Search Consultant at The Mullings Group VP of Medical & Clinical Affairs – Bay Area – Hematology Biologics/Device Ground breaking biologic company based in the Bay has discovered a proactive procedure for blood transfusion. We are looking for a VP of Medical & Clinical Affairs.

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Must have: • MD degree • Phase III clinical trial experience • Willing to travel 30% internationally • Hematology or oncology experience I would like to share more information with you. Please send me a copy of your resume to Giovanni@MullingsGroup.com ************************************************************* Posted by Jeff Randles, Account Manager - Sr. Recruiter at Precept Life Sciences Contract Regional CRA in Los Angeles, CA Now hiring: Contract Regional CRA in Los Angeles, CA http://www.ziprecruiter.com/job/Contract-Regional-CRA-in-Los-Angeles-CA/bd74e788/?source=social-linkedin-group-jobs ***************************************************** Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Trials Manager Now hiring: Clinical Trials Manager http://www.ziprecruiter.com/job/Clinical-Trials-Manager/e25f445c/?source=social-linkedin-group-jobs *********************************************************** Posted by Isabel Brito, Atlantic Management Resources Please send resumes to ibrito@amrjobs.com Looking for top-performing, entrepreneurial women's health/OBGYN sales representatives in Glendale, CA. Looking for top-performing, entrepreneurial women's health/OBGYN sales representatives in Glendale, CA. Must have at least 2 years of current, related experience. This is a fun opportunity to work for a small, growing company. ************************************************************** Posted by Mohammed Nadeem, HR http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=215307304&gid=61852&trk=eml-anet_dig-b_jb-ttl-cn&ut=0cl-7BPckCilE1 Job**Job**Job as CASE MANAGER at South San Francisco,CA.Skills: Healthcare reimbursement,benefit investigation, payor reimbursement policies,reimbursement support.Pls send resume to ... Looking for a Case Manager in South San Francisco, CA Provides customer focused reimbursement support to patients, distributors, physicians and internal sales force. Educates, informs, and assists patients and providers to navigate through the reimbursement process. Identifies barriers to reimbursement and continually identifies and recommends program efficiencies to the team to promote high quality of work by Access Solutions/GATCF staff. Identifies and facilitates referrals to alternative coverage options and financial assistance programs for patients who are under insured or require copy assistance. Skills: 3 years experience in Healthcare reimbursement. Must have proven outstanding customer service experience.

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Proficient in all aspects of reimbursement (i.e. benefit investigation, payor reimbursement policies). Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format. Ability to work collaboratively in a team structure and responsibly delegates next steps to appropriate team members. Demonstrates effective problem solving and excellent customer service. Exceptional attention to detail and ability to prioritize tasks. Requires computers skills including MS Excel. Education: BA or BS degree REQUIRED. http://bull.hn/l/10S5B/ ********************************************************

Jobs that Crossed My Desk Through Feb. 16, 2013 ******************************************************* Apply on company website Resource Manager - can also be known as Staffer, Location Manager or Staff Coordinator IMS Consulting Group- Bay Area (San Francisco Bay Area) Job Description Operating as a US Resource/Staffing Manager within the global resourcing team, to ensure the effective deployment of US West-Coast based consulting delivery team onto projects, business development opportunities and internal IMS Consulting Group initiatives. Through resourcing decisions, support the effective onboarding, development and retention of US based Consulting delivery team members. Principal Accountabilities:

Identify and resource West Coast consulting team members to client projects, business development opportunities, thought leadership and IMS Consulting Group internal initiatives.

Collaborate effectively with global resource management team todeploy consulting delivery team members in a manner that optimizes overall productivity while meeting individual development objectives.

Engage with the principals and other senior leaders to understand, plan for and ultimately meet the resourcing/staffing demands of their pipeline.

Enable and support development goals of West Coast analyst consulting delivery team through resource management decisions.

Monitor and communicate current and planned delivery capacity Maintain resource management data integrity in the PSA system that supports resource

and project management decisions Identify resourcing capability gaps in the analyst to senior consultant team as an input

to hiring and to support the development of training plans. Actively participate in the annual review process, providing insight to consultant

development and career progression Act as point of contact for training and other career opportunities

Desired Skills & Experience Bachelors degree or equivalent Prior resourcing or consulting delivery experience in a professional services environment Proven problem-solving skills with attention to detail Strong written and verbal communication skills Ability to build strong business relationships and influence with key stakeholders at all

levels within the business

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Excellent team-based interpersonal skills with ability to work independently Ability to demonstrate determination, diplomacy and resilience Ability to rapidly assimilate multiple types of information from a variety of sources for

effective decision making Proficient in Microsoft Office applications Knowledge of life science consulting is a plus

Company Description IMS Consulting Group is the world’s leading, specialized advisor on critical business issues in the life sciences, and is the management consulting arm of IMS Health, a leading provider of information, services and technology for the healthcare industry in 100+ countries around the world. Our IMS Consulting Group teams offer end-to-end management consulting in key issues areas that include: business unit, therapy area and brand strategy, portfolio strategy, launch strategy, pricing & market access studies and commercial model design and optimization. IMS Consulting Group is an Equal Opportunity Employer.We cultivate a diverse corporate culture across the 100+ countries where we operate, celebrating and rewarding teamwork and inclusiveness. By embracing our differences, we create innovative solutions that are good for IMS, our clients, and the advancement of healthcare everywhere. Additional Information Posted:January 23, 2013 Type:Full-time Experience:Mid-Senior level Functions:Management Industries:Management Consulting Job ID:4683292 ********************************************************** Posted by Jennifer Harvey, HR, Veracyte

Client Services Specialist

Now hiring: Client Services Specialist http://www.ziprecruiter.com/job/Client-Services-Specialist/be42a8fa/?source=social-linkedin-group-jobs

______________________________________________________ Medical Billing Specialist - Temp Position

Now hiring: Medical Billing Specialist - Temp Position http://www.ziprecruiter.com/job/Medical-Billing-Specialist-Temp-Position/0bff4c8d/?source=social-linkedin-group-jobs

********************************************************** Posted by Pharmalink Consulting - San Diego Director of Regulatory Affairs Pharmalink Consulting- San Diego (Greater San Diego Area) Job Description Our client is seeking a Consultant at the Director level for a long term project. As Regulatory Affairs Director at this successful and established pharmaceutical company, your responsibilities will include:

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• Leading regulatory affairs sub team and creating Global Regulatory Affairs Strategic Plan. • Coordinate global submission activities, lead global/regional submission activities • Providing strategic input into product lifecycle plans and maintain licences for marketed products. • Becoming the day to day contact point with regulatory authorities for communications relating to assigned projects. • Managing and coordinating requests for scientific advice with regulatory agencies. • Directing regulatory strategy and contributing to its outcome for assigned projects. Desired Skills & Experience • 7+ years of regulatory experience and a good understanding of US regulatory processes. • Biotech experience is preferred but not required. • Extensive submissions experience. • Excellent leadership and people management skills. • Ability to manage multiple projects and tasks. • Life sciences degree. • Good knowledge of the global regulatory environment. • Ability to direct regulatory strategy and contribute to its outcome when necessary Company Description Pharmalink Consulting is the No 1 choice for sustainable outsourcing for all Regulatory Affairs requirements. We can resource any Regulatory Affairs project – regardless of size and timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world. Unlike some other consultancies, Pharmalink specialises in Regulatory Affairs only. The business has become so specialised in the last 10-15 years, it requires dedicated teams of Consultants to meet the increasingly complex demands of local health authorities and keep abreast of all the changes that are constantly happening on a global and local market level. For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com Additional Information Posted:February 12, 2013 Type:Contract Experience:Director Functions:Consulting Industries:Pharmaceuticals Job ID:4861120 ******************************************************* Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this job. Associate Director Clinical Operations – Full Time Position (San Francisco Bay Area) PPBI To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. SUMMARY: The Associate Director, CTM will be responsible for the successful execution of Clinical Trials when outsourced to strategic CRO partners and Clinical Trial Management infrastructure deliverables. This individual will work in partnership with Medical Directors, Regulatory, Biostatistics, Research Directors and, critically, external partners. As a leader within the organization, the incumbent will be instrumental in the concept, design, growth and deliverables of the clinical trial management function as it relates to external partnerships to assure the highest quality delivery of Clinical Programs, on time and within budget.

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JOB RESPONSIBILITIES: • Support the Senior Director, Clinical Operations in clinical trial execution with external partners. • Manage clinical operations staff. • Act as operational lead for relationships with CROs where a strategic partner is in place. • Achieve clinical trial program execution within budget, on time, and of the highest quality, through cross-company and cross-partnership collaboration. • Identify and communicate clinical development risks and mitigation strategies as they relate to strategic partners. • Partner with the organization to optimize cross-functional communication. • Act as a lead for process optimization between CRO partners. • Assess and allocate resources for clinical projects; establish a systematic scalable approach for future project and portfolio enhancement based on risk management principles. • Support integration of Company and CRO teams and process to enhance success of new collaborations. EXPERIENCE AND QUALIFICATIONS: • Advanced degree in science or equivalent combination of relevant educational and professional experience is required; prior research and / or clinical training is desired. • Minimum of 10 years of experience and success in a clinical project/ trial management role within another biotech / pharmaceutical company, which shall include at least 3 years of experience working with CRO partnership. • Late stage clinical trial experience (Phase 3 or 4) preferred. • Direct Management experience of clinical operations personnel. Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com ******************************************************* Posted by Shelly Glasgow, Technical Recruiter at ProPharma Group Quality Engineer (APR) Consultant - Bay area Now hiring: Multiple Quality Engineer (APR) Consultants - Bay area. For immediate consideration, apply online at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Quality-Engineer-APR-Consultant-Bay-area/3a2c7d30/?source=social-linkedin-group-jobs ****************************************************** Posted by Shelly Glasgow, Technical Recruiter at ProPharma Group Quality Engineer (APR) Consultant - Bay area Now hiring: Multiple Quality Engineer (APR) Consultants - Bay area. For immediate consideration, apply online at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Quality-Engineer-APR-Consultant-Bay-area/3a2c7d30/?source=social-linkedin-group-jobs ******************************************************

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If you are qualified and interested please contact me privately at dave@alpinesearch.net, or pass this information along to others as appropriate. Thanks- Dave Murphy The Alpine Group Associate Director of Marketing - SF Bay area A client of mine in the pharma business has asked me to help them fill a new marketing position at the AD level, responsible for inline brand managment and lifescycle planning in the CNS market. With the accelerating contraction of the pharma business it's increasingly rare to find companies willing to go external to fill AD / Director / VP roles but that's the case here. You will lead a small team of 2-3 Product Managers and the organization has doubled sales in the past two years so opportunity abounds for career development. Requirements include: 6+ years of marketing / brand management experience in the pharmaceutical industry Experience supervising other marketing personnel Pharmaceutical sales experience Bachelor's degree or better; MBA preferred Strong interest in working for a small to mid-size organization where the teams are small and the duties vary considerably ****************************************************** http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=213500934&gid=61852&trk=eml-anet_dig-b_nd-pst_ttle-cn&ut=2QSluhCaHd7lE1 Started by Lisa De Benedittis Biotech / Pharma Recruiter, Biotech, Pharmaceutical, Medical Device Recruiter @ Elite Recruiting Services, Inc. Chief Medical Officer, Hematology / Oncology - Biopharma - So. CA Chief Medical Officer, Hematology / Oncology - Biopharmaelitestaffingsvc.com Chief Medical Officer, Hematology / Oncology The Chief Medical Officer will provide hands-on leadership on the hematology and oncology medical strategy and drive execution of key deliverables The CMO will be responsible for... ****************************************************** Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Contact cheryl@biophaseinc.com if interested! Packaging Technician (Santa Clara, 6 months temp, $14-15/hr) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Packaging Technician to work for a leading Bay Area biotechnology company. Packaging Technician (Santa Clara, 6 months, $14-15/hr) This position is responsible for manufacturing and assembling products as required by the production schedule. Included are all production reagents which form the kit components, from the raw materials through to bottled and labeled finished goods. Capable at change-over and operation of all labeling and packaging equipment. Prints computer generated labels. Responsible for mastering all existing and new packaging equipment and processes to bottle, label, and package product, including the printing of computer generated labels. Follows appropriate guidelines established by the Manufacturing Process Instructions (MPI), Standard Operating Procedures (SOP), Equipment Operating Procedures (SOP) and Process Guidelines (PG). Satisfy due dates as specified in the Master Schedule with high quality product at or below cost targets.

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Works closely with QC, Reagent Chemistry, Materials and other production persons for work order priority, materials needs, line clearances, and work order completion. Ensures final components meet specifications working closely with QC and other production persons. Conducts in-process checks of packaged product as required. Assists in the training of new hires and temporary employees in the production process. Maintains an orderly and clean working environment Familiarity with basic laboratory devices and equipment plus some mechanical aptitude. Mathematical computation is necessary to compile data for completing batch records. Good oral and written communication skills, organizational abilities, flexibility, attention to detail and positive interpersonal skills are essential to this position. Must be able to use a computer and have a working knowledge of Microsoft Office and Excel. Local candidates only will be considered at this time. If you are not local but plan to relocate, please let us know. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. ******************************************************* Posted by Gregg Baker, INSOURCE GROUP (812-430-8927), SEARCH CONSULTING, LION (I Never IDK); Among top 1% most viewed Profiles in 2012. If this describes you and you would like to investigate this opportunity in more detail, please contact me at gregory.baker@wowway.com or 812-430-8927. Strategic Account Service Delivery Manager - Southern California In this strategic Big Pharma Account, my client's strategic account service delivery manager oversees the presentation of services to clients while making sure the service levels are effective. They provide the crucial communications link between the customer's senior managers and the service operation which includes 70+ FTE. The successful candidate will provide account management leadership for a key account's analytical instrument laboratory asset management. They will provide the leadership required exceed the customer's service performance measures and deliverables and will anticipate customer needs, investigate underlying causes and identify short term or long term solutions. Ideally, you will have experience as a analytical instrument field service engineer (for Thermo, PerkinElmer, Bruker, Shimadzu, AB Sciex, Waters, Quest Diagnostics or comparable companies), then moved on to a managerial role in service delivery to a set of accounts or key accounts for laboratory asset management projects. **************************************************** Posted by Taylor Langston, Social Media & Sales Support Specialist at PharmacyWeek, Inc. Pharmacy Clinical Informaticist, Salinas Valley Mem Hlth Sys, Salinas, CA CPS http://www.pharmacyweek.com/job_seeker/listings/listing.asp?listing_id=14788&location_id=72767 _________________________________________________ Pharmacist (Program Specialist-Procurement), Department Of Veterans Affairs, Palo Alto, CA http://www.pharmacyweek.com/job_seeker/listings/listing.asp?listing_id=15001&location_id=72294 *******************************************************

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Started by Jon Hauptman, President, The Hauptman Group Healthcare Search Consultants Specialty Pharma Rep (Pain) Positions- San Jose, San Diego, Bakersfield, Valencia, Phoenix! APPLY DIRECT to www.thehauptmangroup.com STRONG specialty pharmaceutical organization is looking for a proven "go-getter" who has a consistent track record of success within the pain management (pharma) arena. Must Have QUALIFICATIONS: 4-Year Degree 3+ Yrs Pharma Sales Relationships w/ Pain Management and/or Orthopedics preferred Decorated with Documented Track Record of Exceeding Sales Quota Top Performers, only! No job hoppers. Salary + Bonus : $100k - $130k Great Benefits: Car, Medical, Dental, GREAT 401k, etc.. Specialty Pharma Rep - San Josepcrecruiter.net *********************************************************** https://jobs.smartbrief.com/action/listing?listingid=57BFCAE2-207D-40D8-A067-60343ED6CC7C&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Sr. QA Manager - Quality Systems (Santa Barbara) Allergan Job Description Responsible for Quality System Harmonization Project while ensuring compliance of Allergan Medical’s Quality System with 21 Part 820, Part 11, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive), Canadian Medical Devices Regulations, and other applicable international regulations. Responsible for monitoring and improving Quality System processes, and leading quality system integration among multiple Allergan Medical locations, including evaluating processes and writing procedures. Manage the Allergan Medical Quality System Harmonization Project and function as the main liaison with Allergan management and site leaders. Establish detailed project timelines & tasks, including review points. Provide technical expertiseOversee activities and inputs/outputs of other team members. Create external requirements matrix. Generate matrices. Review QS documentation -determine compliance status and needed. Create or advise on needed remediation (process analysis, SOP creation). Monitor ongoing project status and day-to-day management. Responsible for issue/risk management. Authorized to stop/modify project activities. Responsible for tracking project budget.

Bachelor’s degree in engineering, sciences, or business. MS in engineering, sciences or business administration (MBA) is preferred. ASQ Certification is desired. Six (6) years of experience in Quality or Manufacturing within the Medical Device

industry. Additional four (4) years in Quality Management. Minimum of 10 years analyzing regulations and writing procedures and developing

processes and quality systems, affecting multiple locations.

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Knowledge of the listed regulations/standards is required: FDA’s 21 CFR Part 820 (Quality System Regulation), CFR Part 806 Medical Device Reporting, and 21 CFR Part 11 (Electronic Records; Electronic Signatures), ISO 13485:2003, Council Directive 93/42/EEC June, 1993 (Medical Device Directive), and the Canadian Medical Device Regulations, ISO 14971 (Risk Management).

Essential Skills and Abilities Demonstrated ability to lead a technical team. Demonstrated ability to make effective and timely decisions related to quality,

technical, and business issues with high risk or consequences to a business area. Excellent written and verbal communication skills. Effectively communicates both up and down the organization and maintains a customer

focus. Previous experience with Ministry of Health (MOH) inspections and responses. Previous experience in conducting FDA regulated recalls or field corrections. Excellent planning and prioritization skills with the ability to multi-task and adapt. Ability to identify, define and resolve problems using a structured methodology such as

KTA. Ability to analyze training needs. Ability to guide and delegate to subordinates.

******************************************************** https://jobs.smartbrief.com/action/listing?listingid=204F07A8-2717-45A8-9302-175B0507664F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Engineer, Process Development ArthroCare Corporation Job Description

Engineer, Process Development Irvine, CA

ArthroCare Corporation (Nasdaq:ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation(R) technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS(R) line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology. Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development. Summary: Design, Develop, Implement and Maintain Manufacturing Processes for assigned ArthroCare lines of products (devices). Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)

Responsible for developing and implementing new processes on new products and be the M.E. representative on development teams for designing, developing,

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implementing, and maintaining assembly, test, and packaging processes. Ensures that time lines, cost and quality expectations are met.

Develop new techniques for assembly and test, including test fixtures, with DOE and validating new processes, evaluate failure data from field to find root cause and implement sound engineering solutions.

Responsible for training techs and assemblers and supporting transfer of product into manufacturing facilities.

Provide accurate tracking and reporting on this activity. Provide continuous engineering support on assigned products to maintain and improve

margin, performance and quality. Work with R&D team leader to deliver acceptable documentation on product (including

but not limited to: Assembly and test fixtures, Routers, MPI, Test methods, Drawings and Specs) in a timely manner.

Participate and Manage (as required) engineering builds, verification and validation builds, and provide technical data/ report to the team leader.

Ensure compliance with ArthroCare quality system and all relevant internal procedures and policies (including but not limited to: ECN, NCR, CPR, BOM, Router, MPI/ SOP).

Work on cost reduction projects to reduce material/ process costs by defining and implementing new techniques and equipment/ fixtures for assembly and test. This may require designing fixtures and implementing in manufacturing facilities.

Assist and lead product and process transfers to Costa Rica manufacturing facility. Supervisory Responsibilities: Technicians and/ or clean room personnel as required Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Education and/or Experience:

Essential. B.S. or M.S. degree in Engineering. At least 3 years in related field. Prefer experience in medical and surgical devices, and implantable biomaterials.

Language Skills: Excellent communication skills, and problem solving skills. Ability to plan and schedule multiple projects and tasks. Fluent in Spanish a plus. Mathematical Skills: Needed for engineering position Reasoning Ability: Need to be able to make rapid and sound decisions Computer Skills: Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works. Certificates, Licenses, Registrations: None Other Skills and Abilities: Be able to work with people at all levels of organization and understanding of MRP and document control software. Other Qualifications: Assembly and test fixture designing skills. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.

For consideration of this position and other opportunities please visit our career center at: http://careers.arthrocare.com

Equal Opportunity Employer

www.ArthroCare.com Requirements: Site for Posting English Required Expertise Engineering - Process Development Type of Job Full Time Work Location(s) CA - Irvine Required Years of Experience 3-5 Years ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=AB355F96-80F8-44D4-A925-7DA25F973B50&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0

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DIR OPERATIONS, Milpitas Site - 130000007R Abbott Job Description The Director of Operations is responsible for managing the planning, development, implementation, and maintenance of the operations at the AMO Milpitas site. This includes overseeing production, manufacturing, processes, and operations for new and existing products through subordinate management personnel. Will direct the strategies and tactics of the site including matrix management of a broad multi-disciplined organization and providing direction and leadership. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Responsible for implementing and maintaining the effectiveness of the quality systems. 2. Directs the AMO Milpitas Site and Manufacturing Operations, and is responsible for all major Compliance systems (Quality, Procurement, Production, EHS, Scheduling, Costs) used in insuring the marketplace receives world-class products (Phacoemulsification Systems, Excimer Laser Systems, Femtosecond Laser Systems, Ophthalmic Diagnostic Systems) at a competitive cost and on-time. 3. Will lead Milpitas Site; but must work effectively with peer leaders in Global Operations and with other key functions within AMO (Quality, Regulatory, Legal, HR, R&D, Finance, Sales & Marketing) to obtain world-class results. 4. Will develop the strategic, capital, and business plans, including annual budgets for Operations to assure attainment of Standard Costs targets, Quality & Reliability targets, Capital targets, New Product Introduction targets, and Inventory targets. 5. Drives development and implementation of key Strategic and Business Plans to meet Quality, Cost, and Delivery commitments. Develops annual budgets and establishes other key performance metrics/goals (in concert with AMO Global Operations and AMO Senior Leadership Team). Drives for needed results within the established Management review process to maximize the return on assets for AMO Milpitas. 6. Leads development and implementation of systems, policies, and procedures to assure compliance to all key areas (Quality, Procurement, Production, Distribution & Warehousing, Advanced Engineering, HR, and Finance). 7. In collaboration with Divisional and Corporate Quality Assurance, manages AMO Milpitas resources to effectively manufacture quality products per AMO Milpitas Quality System; which is fully compliant with GMP, ISO standards and EHS requirements. Ensures that Regulatory requirements are met. 8. In Collaboration with Divisional R&D; lead the Advanced Engineering efforts to improve DFx, Reliability, and Costs. Drive efforts to influence early design decisions that impact quality, reliability, and costs 9. Creates and maintains a work environment of participation, open communication, and recognition. Develops the appropriate organizational structure and skills to be successful in the achievement of strategies. Recruits, develops, coaches, and mentors senior leadership and management. Provides leadership and actively participates in the Global Manufacturing Team. Demonstrates global alignment by effective working relationships with peers.

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REQUIRED SKILLS: Minimum of a Bachelor’s degree in business, engineering, science, or manufacturing management or related technical field. Advanced degree in related field preferred. Minimum Experience: 8 – 10 years of management experience in a manufacturing environment. Minimum of 5 years personnel management and medical device management. Cross-functional management experiences in product development, engineering, manufacturing, quality, and OEM relationship management preferred. Demonstrated experience in spend analysis PPV, CPI, and cost reduction in a new product production environment desired. Experience with medical device product production preferred. ******************************************************** https://jobs.smartbrief.com/action/listing?listingid=463F74FC-A105-459E-BCEC-3825DF9093F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Director of Global Infrastructure - 002196 Edwards Lifesciences Job Description Leadership: * Achieve excellence in defining, developing and deploying business-centric IT solutions * Champion change and effectively manage the implementation of new ideas * Provide leadership and management over the Irvine Infrastructure team * Provide leadership and support for regional IT resources * Promote the company through attendance and speaking engagements at industry conferences or involvement in local business organizations Departmental Management: * Define, develop, present to management, gain acceptance and approval of ITLT or CIO a plan that is aligned and coherent with an overall Global IT strategy plan * Lead global implementations, and provide technical oversight to regional IT projects to ensure they are in-line with global standards * Work with RMs, stakeholders and regional IT resources to assess and respond to day-to-day business IT needs * Hold regular departmental meetings to review strategic goals and initiatives, promote teambuilding and work to provide growth paths for staff * Supervise the ongoing operations of the Desk Top Support providing quality and timely support to Edwards employees concerning hardware and software needs * Lead recruiting, hiring, on-boarding and training for IT support staff * Administer the department budget * Defines and enforces standard company policies and procedures as it relates to Global Infrastructure * Serve on planning and policy-making committees as required Teamwork: * Reinforce team approach to problem resolution, especially as it pertains to working with the global IT team * Support and solicit input from team members at all levels within the organization Client Management: * Communicate effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, with always an eye toward a single, global solution * Continually define ways to increase internal client satisfaction and deepen client relationships * Provide senior level resolution to internal and external client issues Infrastructure and Desktop solutions (Hardware and Software): * Establish global infrastructure and application solution standards * Identify emerging information technologies to be assimilated, integrated, and introduced within the regional infrastructure fabric * Oversee the commissioning of infrastructure to ensure that it is harmonized with global standards, so that Edwards employees always have the same experience, “anywhere, anytime” * Oversee the testing, selection and implementation of new desktop solutions and changes to existing solutions that are (1) global in nature; and (2) localized just enough to meet the statutory and regulatory requirements in the region * Serve as primary contact with outside vendors in the generation of RFPs, bids, contracts, agreements, and other major vendor interactions Systems Operations and Maintenance: * Oversee the integrity and continual operation of the global network, including LAN/WAN and data center services * Ensure the continual functioning of mission critical infrastructure, application solutions and operations * Maintain security and privacy of the information

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systems, communication lines, and equipment * Define, develop, review, and certify all back-up and disaster recovery procedures and plans * Oversee IT related aspects of all the regional construction and renovation projects Education, Skills and Abilities: * B.S. degree in computer science, computer engineering, electrical engineering or related field, a Master’s degree is a plus * Ten years management/leadership experience, including deployment and management of global infrastructure an on a large scale * Experience moving or building a data center is highly preferred * Strong analytical and logical problem solving skills * Strong interpersonal communication and relational skills * Proven organizational and project management skills, working in a satellite location of a multi-national corporation, preferably US-based * User-centered attitude and willing to work in a team oriented environment that serves a diverse population * At ease in a matrix organization * Speaks English as a first language * Possess and displays sound judgment; initiative; flexibility and detail-orientation ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=16D1F2B2-AEF0-47FF-8038-58D1C97CB054&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Neurovascular Intervention Marketing Manager Asahi Intecc Job Description Asahi Intecc is a manufacturer of Disposable Medical Device that specializes in Coronary and Endovascular Products for the Interventional Market place. We are now hiring staff for Neurovascular Intervention Products. This position will be responsible for the marketing of Neurovascular intervention products. Responsibility includes - Product training to phycicians and lab staff - Promotion planning and implementation - Tradeshow planning and implementation - Clinical case observation and market feedback - Market analysis and marketing plan implementation - Clinical support for sales rep in the field - planning and preparation of marketing tools - Building a key opinion leader network ● Min 3yrs experience of Neurovascular Intervention Product Sales or marketing experience ● About 50% travel ***************************************************** Posted by Dave Catlin, Managing Director

To apply, submit resumes to jobs@genquestbio.com Clinical Trials Project Manager - SF Bay Area The selected candidate will oversee the conduct of all clinical studies performed and ensure studies are completed on time within budget and in compliance with SOP’s, FDA regulations and ICH/GCP guidelines. You will work as part of a cross-functional team to ensure completion of the project clinical goals and act as a primary interface with the CRO. You will manage communications between

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monitors, clinical sites and the CRO including the implementation and execution of clinical programs, development and administration of site and vendor budgets. You will coordinate with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals and resources. You will assist in the writing of protocols, the design of case report forms and other study documents as you work closely with external service vendors to oversee all aspects of the clinical trials. You will evaluate, tabulate and may prepare written summaries of clinical data. You will ensure compliance with protocol, overall clinical objectives and FDA/IHC requirements including conducting a review and source verification of clinical data to ensure timely resolution of data queries. Maintain contact with clinical investigators and staff and track all required site documentation. Qualifications include a BS/MS degree or equivalent in the life sciences, or a related technical degree with 8+ years of experience. Experience managing multi site trials, CRO’s and other vendors is required. You should also have experience in Clinical Trial Management, specifically demonstrating application of research methodology in a clinical trial setting. You should have thorough knowledge of GCP/ICH requirements and possess excellent oral and written communication skills. This position may supervise administrative support and other clinical staff and may be required to travel to clinical sites occasionally. This is a contract opportunity for approximately 6+ months in duration with the potential to convert to regular status. No relocation is offered for this position. ********************************************************* Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Project Coordinator Now hiring: Clinical Project Coordinator http://www.ziprecruiter.com/job/Clinical-Project-Coordinator/d6c54142/?source=social-linkedin-group-jobs ********************************************************* Qualified candidates please reply to: Cindy Johnson cjohnson@chozeninc.com tel: 925-577-8135 Below you will find an update on our most urgent openings in medical device in the San Francisco bay area. Most Urgent Positions: International Sales & Marketing Specialist Customer Service Specialist Product Manager SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT International Sales & Marketing Specialist

BA/BS degree International sales & marketing support experience (intl tradeshows, campaigns, etc) Experience designing & executing International Email Marketing, Mobile/SMS, Social

Media campaigns Foreign language skills strongly preferred (Spanish, Portuguese, Russian, Chinese or

Japanese would be ideal) Ability to travel up to 25% Medical device industry experience would be a plus (not required) Knowledge of Salesforce.com, MS Office, Access, Publisher and Project, Dreamweaver,

Fireworks, Flash, Freehand, Illustrator, Photoshop Customer Service Specialist

BA/BS degree

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4+ years of customer service experience, medical device industry preferred Exceptional documentation skills, especially with order entry Attention to detail and accuracy are essential. Knowledge of Salesforce.com, MS Office, Access, Publisher and Project, Dreamweaver,

Fireworks, MAS 90 Proven ability to take initiative and learn in a smaller team environment strongly

preferred Product Manager

BA/BS degree Significant knowledge of interventional products, procedures and market trends 3+ years of Product Management experience within medical device industry Excellent written/oral communication skills Ability to travel up to 30% Startup experience would be a plus

******************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=4870697&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3V9a9EIcbP65E1 Senior Program Manager--BEx Real Staffing Group- Santa Ana (Orange County, California Area) Job Description SR. PROGRAM MANAGER BEX The Sr. Program Manager BEX acts as a cross-functional change agent to build & reach consensus on identifying problem areas and pursuing recommended solutions to increase revenue growth, improve productivity and positively impact our customer experience. Develops and supports the senior leadership team in setting the vision for Business Excellence deployment, leads and mentors strategic complex process improvement projects following the Lean Six Sigma methodologies, and responsible for delivery of Business Excellence related training across the organization such as Lean Six Sigma Belt Training and Change Management Training. CORE JOB RESPONSIBILITIES: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. • Leads strategic, complex process improvement projects in the division. • Delivers strategic results in conjunction with division goals and objectives. • Evaluates business processes and determines initiatives that will yield greater productivity and efficiency to enable growth. • Acts as a cross-functional change agent to drive and sustain measurable BPI for the division. • Act as mentor, role model and coach in the implementation of BEx best practices. POSITION ACCOUNTABILITY / SCOPE: Develops and articulates a strategic vision for areas of responsibility. Leads assigned departments by developing, communicating and building consensus for goals and programs that support division, business unit and company objectives. Able to lead within a matrix organization. Creates mid- to long-range plans to carry out objectives established by top management; develops and calculates a budget for one or more departments to meet organizational goals; forecasts future departmental or group needs including human and material resources and capital expenditures; determines and establishes organizational structure and supervisory relationships subject to top management approval. Typically makes decisions that translate programs established by top management into operational plans and schedules; work is performed without appreciable direction; consequences of erroneous decisions or recommendations would normally result in failure to

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achieve goals critical to the major objectives of the organization and would seriously affect the financial, employment or public relations position of the company. Qualifications • 10+ years in management, 5+ years of direct management responsibility delivering significant strategic results for BPI initiatives. • Current Six Sigma Black Belt certification required; Six Sigma Master Black Belt certification is preferred but not required. • Proven ability to facilitate cross-functional change. • Demonstrated experience in deploying continuous improvement methodologies within a commercial organization (Sales and Marketing) desired. • Experience with direct Lean Six Sigma responsibility of delivering significant strategic results for continuous improvement initiatives preferred. • Strong project management skills & proficient with Lean Six Sigma tools and methods (DMAIC & DFSS) desired. • Excellent training and presentation skills with solid communication capabilities including oral and written desired. Education: Bachelor's Degree in business or a technical discipline. Company Description Real Staffing is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services and has one of the largest networks of specialist recruiters globally. Our premise is a simple one: by recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time. At Real Staffing we offer retained search as well as contingency recruitment within both the contract and permanent markets. Our consultants are market specialists and it is this in-depth market knowledge that allows our consultants to develop tailored recruitment solutions for this demanding recruitment market. We take the time to understand our candidates' current and future ambitions and actively seek out roles that will help take our candidates to the next level in their career. The strength of our client relationships and global network means we can access the best new roles within the sector. Whether you are looking to strengthen your team or looking for your next career move contact us today. www.realstaffing.com Additional Information Posted:February 13, 2013 Type:Full-time Experience:Not Applicable Functions:Project Management, Manufacturing, Business Development Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:$150K to $165K (depending on experience) Referral Bonus:generous bonus structure Job ID:4870697 *************************************************** http://jobs.celgene.com/go/sales-jobs/305809/?utm_source=Beaker&utm_campaign=Celgene_Tier1 Sales Jobs

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Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 75 countries that is helping to turn incurable cancers into chronic, manageable conditions. Our company’s deep and diverse pipeline of over 25 compounds in clinical development, which address more than 30 serious diseases, is a testimony to this commitment and has created accelerated growth opportunities across the organization. We are expanding our sales teams and seeking talented hematology and oncology sales professionals with a proven track record and the drive and initiative to sell in markets that revolve around complex science. Celgene has been consistently ranked as one of top sales forces in the industry, because of the knowledge and support the sales team demonstrate to improving the lives of the patients we serve. Celgene is an organization that not only recognizes performance, but also the manner in which performance is achieved. We offer an innovative workplace where diversity and cross-functional experiences are embraced, providing individuals an opportunity for continued personal growth and reward. We invite top performers who want to make a difference to consider the opportunity to join our Celgene Sales team. ___________________________________________________________________ http://jobs.celgene.com/go/research-scientist-jobs/305801/?utm_source=Beaker&utm_campaign=Celgene_Tier1 Research Scientist Jobs Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. What is it that defines Celgene? Most fundamentally, Celgene is its employees, who are focused on the mission of delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases. They are a varied group of talented people united in their commitment to discover, develop and market life-enhancing drugs that make a measurable difference in the lives of millions of people. Why Apply for Research Scientist Jobs with Celgene? If you would like to join the team and build on the Company's scientific and commercial achievements, apply for a Research Scientist job with Celgene today. Our goal is to attract the best people at every level of the organization, and you can help us achieve that goal! ****************************************************** https://jobs.smartbrief.com/action/listing?listingid=204F07A8-2717-45A8-9302-175B0507664F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/5/13 Location: Irvine, CA Years Experience: 3+ in related field Engineer, Process Development ArthroCare Corporation Job Description

Engineer, Process Development

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Irvine, CA ArthroCare Corporation (Nasdaq:ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation(R) technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS(R) line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology. Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development. Summary: Design, Develop, Implement and Maintain Manufacturing Processes for assigned ArthroCare lines of products (devices). Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)

Responsible for developing and implementing new processes on new products and be the M.E. representative on development teams for designing, developing, implementing, and maintaining assembly, test, and packaging processes. Ensures that time lines, cost and quality expectations are met.

Develop new techniques for assembly and test, including test fixtures, with DOE and validating new processes, evaluate failure data from field to find root cause and implement sound engineering solutions.

Responsible for training techs and assemblers and supporting transfer of product into manufacturing facilities.

Provide accurate tracking and reporting on this activity. Provide continuous engineering support on assigned products to maintain and improve

margin, performance and quality. Work with R&D team leader to deliver acceptable documentation on product (including

but not limited to: Assembly and test fixtures, Routers, MPI, Test methods, Drawings and Specs) in a timely manner.

Participate and Manage (as required) engineering builds, verification and validation builds, and provide technical data/ report to the team leader.

Ensure compliance with ArthroCare quality system and all relevant internal procedures and policies (including but not limited to: ECN, NCR, CPR, BOM, Router, MPI/ SOP).

Work on cost reduction projects to reduce material/ process costs by defining and implementing new techniques and equipment/ fixtures for assembly and test. This may require designing fixtures and implementing in manufacturing facilities.

Assist and lead product and process transfers to Costa Rica manufacturing facility. Supervisory Responsibilities: Technicians and/ or clean room personnel as required Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Education and/or Experience:

Essential. B.S. or M.S. degree in Engineering. At least 3 years in related field. Prefer experience in medical and surgical devices, and implantable biomaterials.

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Language Skills: Excellent communication skills, and problem solving skills. Ability to plan and schedule multiple projects and tasks. Fluent in Spanish a plus. Mathematical Skills: Needed for engineering position Reasoning Ability: Need to be able to make rapid and sound decisions Computer Skills: Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works. Certificates, Licenses, Registrations: None Other Skills and Abilities: Be able to work with people at all levels of organization and understanding of MRP and document control software. Other Qualifications: Assembly and test fixture designing skills. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.

For consideration of this position and other opportunities please visit our career center at: ********************************************************* https://jobs.smartbrief.com/action/listing?listingid=463F74FC-A105-459E-BCEC-3825DF9093F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/8/13 Location: Irvine, CA Salary Range: Open Years Experience: 10 Director of Global Infrastructure - 002196 Edwards Lifesciences Job Description Leadership: * Achieve excellence in defining, developing and deploying business-centric IT solutions * Champion change and effectively manage the implementation of new ideas * Provide leadership and management over the Irvine Infrastructure team * Provide leadership and support for regional IT resources * Promote the company through attendance and speaking engagements at industry conferences or involvement in local business organizations Departmental Management: * Define, develop, present to management, gain acceptance and approval of ITLT or CIO a plan that is aligned and coherent with an overall Global IT strategy plan * Lead global implementations, and provide technical oversight to regional IT projects to ensure they are in-line with global standards * Work with RMs, stakeholders and regional IT resources to assess and respond to day-to-day business IT needs * Hold regular departmental meetings to review strategic goals and initiatives, promote teambuilding and work to provide growth paths for staff * Supervise the ongoing operations of the Desk Top Support providing quality and timely support to Edwards employees concerning hardware and software needs * Lead recruiting, hiring, on-boarding and training for IT support staff * Administer the department budget * Defines and enforces standard company policies and procedures as it relates to Global Infrastructure * Serve on planning and policy-making committees as required Teamwork: * Reinforce team approach to problem resolution, especially as it pertains to working with the global IT team * Support and solicit input from team members at all levels within the organization Client Management: * Communicate effectively with internal clients to identify needs and evaluate alternative business solutions and strategies, with always an eye

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toward a single, global solution * Continually define ways to increase internal client satisfaction and deepen client relationships * Provide senior level resolution to internal and external client issues Infrastructure and Desktop solutions (Hardware and Software): * Establish global infrastructure and application solution standards * Identify emerging information technologies to be assimilated, integrated, and introduced within the regional infrastructure fabric * Oversee the commissioning of infrastructure to ensure that it is harmonized with global standards, so that Edwards employees always have the same experience, “anywhere, anytime” * Oversee the testing, selection and implementation of new desktop solutions and changes to existing solutions that are (1) global in nature; and (2) localized just enough to meet the statutory and regulatory requirements in the region * Serve as primary contact with outside vendors in the generation of RFPs, bids, contracts, agreements, and other major vendor interactions Systems Operations and Maintenance: * Oversee the integrity and continual operation of the global network, including LAN/WAN and data center services * Ensure the continual functioning of mission critical infrastructure, application solutions and operations * Maintain security and privacy of the information systems, communication lines, and equipment * Define, develop, review, and certify all back-up and disaster recovery procedures and plans * Oversee IT related aspects of all the regional construction and renovation projects Education, Skills and Abilities: * B.S. degree in computer science, computer engineering, electrical engineering or related field, a Master’s degree is a plus * Ten years management/leadership experience, including deployment and management of global infrastructure an on a large scale * Experience moving or building a data center is highly preferred * Strong analytical and logical problem solving skills * Strong interpersonal communication and relational skills * Proven organizational and project management skills, working in a satellite location of a multi-national corporation, preferably US-based * User-centered attitude and willing to work in a team oriented environment that serves a diverse population * At ease in a matrix organization * Speaks English as a first language * Possess and displays sound judgment; initiative; flexibility and detail-orientation ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=AB355F96-80F8-44D4-A925-7DA25F973B50&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Job Summary Date Posted: 2/12/13 Location: San Jose, CA Salary Range: Open Years Experience: 8-10 DIR OPERATIONS, Milpitas Site - 130000007R Abbott Job Description The Director of Operations is responsible for managing the planning, development, implementation, and maintenance of the operations at the AMO Milpitas site. This includes overseeing production, manufacturing, processes, and operations for new and existing products through subordinate management personnel. Will direct the strategies and tactics of the site including matrix management of a broad multi-disciplined organization and providing

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direction and leadership. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Responsible for implementing and maintaining the effectiveness of the quality systems. 2. Directs the AMO Milpitas Site and Manufacturing Operations, and is responsible for all major Compliance systems (Quality, Procurement, Production, EHS, Scheduling, Costs) used in insuring the marketplace receives world-class products (Phacoemulsification Systems, Excimer Laser Systems, Femtosecond Laser Systems, Ophthalmic Diagnostic Systems) at a competitive cost and on-time. 3. Will lead Milpitas Site; but must work effectively with peer leaders in Global Operations and with other key functions within AMO (Quality, Regulatory, Legal, HR, R&D, Finance, Sales & Marketing) to obtain world-class results. 4. Will develop the strategic, capital, and business plans, including annual budgets for Operations to assure attainment of Standard Costs targets, Quality & Reliability targets, Capital targets, New Product Introduction targets, and Inventory targets. 5. Drives development and implementation of key Strategic and Business Plans to meet Quality, Cost, and Delivery commitments. Develops annual budgets and establishes other key performance metrics/goals (in concert with AMO Global Operations and AMO Senior Leadership Team). Drives for needed results within the established Management review process to maximize the return on assets for AMO Milpitas. 6. Leads development and implementation of systems, policies, and procedures to assure compliance to all key areas (Quality, Procurement, Production, Distribution & Warehousing, Advanced Engineering, HR, and Finance). 7. In collaboration with Divisional and Corporate Quality Assurance, manages AMO Milpitas resources to effectively manufacture quality products per AMO Milpitas Quality System; which is fully compliant with GMP, ISO standards and EHS requirements. Ensures that Regulatory requirements are met. 8. In Collaboration with Divisional R&D; lead the Advanced Engineering efforts to improve DFx, Reliability, and Costs. Drive efforts to influence early design decisions that impact quality, reliability, and costs 9. Creates and maintains a work environment of participation, open communication, and recognition. Develops the appropriate organizational structure and skills to be successful in the achievement of strategies. Recruits, develops, coaches, and mentors senior leadership and management. Provides leadership and actively participates in the Global Manufacturing Team. Demonstrates global alignment by effective working relationships with peers. REQUIRED SKILLS: Minimum of a Bachelor’s degree in business, engineering, science, or manufacturing management or related technical field. Advanced degree in related field preferred. Minimum Experience: 8 – 10 years of management experience in a manufacturing environment. Minimum of 5 years personnel management and medical device management. Cross-functional management experiences in product development, engineering,

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manufacturing, quality, and OEM relationship management preferred. Demonstrated experience in spend analysis PPV, CPI, and cost reduction in a new product production environment desired. Experience with medical device product production preferred. ***************************************************** Apply on company website Senior GxP Trainer Onyx Pharmaceuticals- San Francisco Bay Area Job Description Summary: This position is responsible for Onyx’s GxP training program. The individual in this position is responsible for conducting and providing GxP training to the Onyx team. Provides leadership in continuous system improvement of the GxP training program. They are also the administrator of the electronic Learning Management System (LMS) and ensure proper training of and course content for GxP personnel. This individual in this position provides leadership in continuous improvement according to GMPs/GLPs and current industry standards. They execute the training program for new and existing employees and are responsible for groups and individual training sessions, including scheduling, training material/media development, presentation and record keeping. Essential/Primary Duties, Functions and Responsibilities:

Responsible for the GxP training program. Develop GxP training content and materials (for electronic and in-person presentation

to the Onyx GxP community. Organize and present training sessions/classes to groups or individuals (on GxP

regulations/industry standards and GxP related Onyx procedures or policies). Assure that required departments are provided training on the regulatory requirements

and pertinent quality topics. Communicate compliance and quality policies on a company-wide basis. Ensure continuous improvement in the training program. Ensure Onyx departments and individuals comply with GxP training requirements. Responsible for tracking GxP training through the electronic Learning Management

System. Responsible for company adherence to GxP training program requirements. Provide GMP orientation for new hires. Administer training program documentation including managing training files, records

and database. Cross-train staff members on techniques for delivering compliance-training classes. Determine the GxP training needs for employees by working with department

management to align the GxP training curriculum with the specific job function. Develop and maintain the Onyx GxP Training website. Stay current in GxP regulations and industry standards that apply to Onyx. QA Support: Participate in FDA inspections, vendor audits and internal audits as

needed. Other duties as assigned.

Requirements Work Experience:

3+ years providing GxP classroom training.

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5+ years in a QA, QC or Manufacturing position in the Biotech/Pharmaceutical/Device industry.

Familiarity with cGMPs/GDP and their application in a pharmaceutical or biologics environment is essential.

QA, QC or Manufacturing experience is required. Must possess working knowledge in database usage, and the ability to work

independently. Requires exceptional organizational and presentation skills, and the ability to effectively interact with diverse groups of people.

Functional/Technical Knowledge & Skills: Excellent oral and written skills. Strong leadership and public speaking skills Strong interpersonal skills, which include a professional demeanor when interacting with

personnel or regulatory authority representatives Knowledge of applications of instruction methodologies for the adult learner Sound and practical judgment in the interpretation and application of appropriate

regulations Able to communicate clearly with a variety of individuals in various departments Must be proficient in the following applications: MS Word, MS Excel, MS PowerPoint, and

MS Exchange/Outlook Ability to quickly learn and master new software applications

Customer & Industry Knowledge: Knowledge of GxP FDA regulatory requirements and industry standards. Knowledge of management and operation of a GxP training program for the

biotech/pharmaceutical industry. Education/Training:

Minimum of a BA/BS degree. Other Requirements:

Must have excellent customer-service orientation and ability to work with little or no direction.

Ability to communicate effectively in a learning and teaching environment. Must be flexible, able to manage multiple tasks, and have strong attention to detail. Ability to effectively communicate with internal and external contacts at all levels. Excellent organizational, written and verbal communication skills.

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:February 13, 2013 Type:Full-time Experience:Associate Functions:Science Industries:Biotechnology Job ID:4870998 ****************************************************** Apply on company website R&D Manager Bio-Rad Laboratories- Pleasanton, CA (San Francisco Bay Area) Job Description

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The R&D Manager, Digital Biology will be responsible for the invention and development of new reagent products for Bio-Rad’s Digital Biology Center. These reagents products will be used on the QX100 Droplet Digital PCR system, and future instrument systems that will expand Bio-Rad’s digital biology presence into additional fields and markets. This is a lead position that requires productive interactions with department leads and key collaborators to develop the product portfolio that meet the desired requirements. Responsibilities include being current with literature and interfacing with key collaborators to identify emerging technologies and the practical application of these technologies. Invent and establish concept feasibility of new products. Develop the physical product specifications and configurations that deliver the optimum product performance. Be a key member of the team that integrates these products with the associated emulsion chemistry and micro-fluidics. This person is expected to be a thought leader in digital biology emulsion chemistry, their applications, and gain a presence in the field through inventions, product commercialization, presentations and publications. These reagent products associated with digital biology systems include enzyme reaction mixes, detection chemistries, reaction additives, emulsion oils and emulsion surfactants. Desired Skills & Experience The R&D Manager, Digital Biology is responsible for new product development of chemistries used on the Bio-Rad digital biology platforms. Job duties include but are not limited to:

Identify emerging technology and practical product solutions through literature research and key collaborations.

Establish R&D plans, product portfolio and product specifications. Develop products according to the plan, with the delivery of physical product

specifications for manufacturing process development, as well as user protocols, and characterized workflow dependencies.

Evolve the development process to be able to launch into regulated markets as well as the research market.

Establish a presence and knowledge through presentations, posters and publications. Generate data that provides detailed performance information associated with the targeted applications.

Ensure all invention disclosure and patent applications are filed in a timely manner. Develop orthogonal analytical assays for product and component characterization. Productive execution of well thought out experiments, accurate recording of experiment

and results, in depth analysis and reporting of results. Company Description Bio-Rad, Inc. ranks among the top five life science companies worldwide, and maintains a solid reputation for quality and innovation. It develops, manufactures and markets a complete range of laboratory products used for research in molecular biology, biochemistry, microbiology, genetics, immunology, and chemistry. The group serves a growing base of customers in academic and biotechnology research, and in the pharmaceutical industry. Recently, the group introduced new products for use in the areas of DNA amplification, proteomics, and food testing, three fields in which Bio-Rad remains at the center of discovery. Bio-Rad is an Affirmative Action/Equal Opportunity Employer Additional Information Posted:February 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Research, Management Industries:Biotechnology Job ID:4872105 ****************************************************** Register on company website

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Started by Ron Bucher, Customer Support and Services Executive Service Logistics Manager position in Sunnyvale, CA Direct applicants only - no recruiters. Must have experience managing service logistics in medical industry. QAD experience highly advantageous. ****************************************************** Posted by Rebecca Janney, Clinical Research Recruiter - Permanent Placement Contact Rjanney@crnspg.com Biopharma in South Bay needs 2 CRAs - rjanney@crspg.com Clinical stage small biopharma is in need of 2 direct-hire, in-house CRAs. Will travel regionally 30-50%. Candidates must possess at least prior co-monitoring experience, all the way through senior level. Competitive compensation! Wear may hats! ****************************************************** Apply on company website https://jobs.smartbrief.com/action/listing?listingid=63D9CFBA-AC3F-4E83-9C6E-6EBC28DAA413&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Counsel II, Legal (Anti-corruption) Gilead Sciences Job Description This position will report to the director of Gilead’s anti-corruption program within Commercial Legal. The individual will help implement an effective cross functional anti-corruption program at Gilead Sciences. The individual will help develop and carry out policies and procedures; provide business conduct and compliance support to Gilead’s emerging markets and international access operations (Gilead’s program to increase access to medicines and healthcare in low- and middle-income countries); assess and act upon issues identified during due diligence processes; assist in implementing training and communication plans; and contribute to monitoring, auditing and enforcement activities to ensure consistent application of Company policies. The individual will work in close coordination with colleagues in Legal, Business Conduct, Internal Audit, Finance, and other departments to complement existing compliance activities. ********************************************************** Contact If interested, contact: Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing T: 215-536-6979 F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com Medical Writer – San Francisco Position with pharmaceutical company is 3-month contract to possible perm. Responsibilities

1. Responsible for supporting CRAs and MDs in clinical protocol development, clinical study reports, Investigator's Brochures, informed consents and INDs/IMPDs. Responsible for researching, writing and editing clinical reports, summarizing data from

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clinical studies for submissions to the FDA and for publication and/or presentation. 2. Will also contribute to the development of medical writing infrastructure. Remains

informed of the latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas. Manages medical writing project timelines and manages all clinical writing activities outlined in the Project Clinical Development Plans. Reviews documents and offers guidance in the preparation of regulatory and publication documents.

3. Organizes, conducts, and leads document production meetings and other meetings as necessary.

4. Responsible for developing and managing, Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, IND sections. Proposes applications

5. Responsible for supporting the development of departmental infrastructure such as contributing to research, acquiring a document management system, establishing style guides, and generation of templates and processes.

Skills 1. An ability to create effective presentations from raw data is essential. 2. An ability to interpret statistical and clinical data is essential. Must have an ability to

work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required.

3. Strong written and verbal communication skills are required. 4. An understanding of clinical research, biostatistics, and regulatory affairs is required. 5. Must have experience writing clinical protocols, clinical study reports, and IND sections.

Good computer skills are required. Working knowledge of MS word, Excel, Power point, Lotus notes is a plus.

Experience 1. A Bachelors/Masters degree in a scientific discipline with a strong journalism

background is required. 2. Equivalent experience may be accepted. 3. A minimum of 8 years in a pharmaceutical, biotech, or CRO medical writing position is

required. 4. A minimum of 6 years writing management experience is also required. 5. A minimum of 5 years previous supervisory experience is required.

*********************************************************************** Contact If interested, contact: Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing T: 215-536-6979 F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com Medical Writing Specialist – Pinebrook, NJ

Position is 11-month contract. Description

1. Uses project management skills to track, review and ensure timely completion of high quality documents.

2. Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.).

3. Independently compiles complete drafts of report appendices for clinical phase 1 /2a studies.

4. Act as a central resource on all format and style related issues to ensure consistency

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within submission related documents prepared by Medical Writing or external partners. Maintain departmental and project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines. Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.

5. Work with key interface partners to facilitate the completion of clinical study reports and their appendices. Ensure clinical documents adhere to global standards and are in accordance with electronic publishing Standards. Checks that study file components (eg, Investigator CV's, protocol and amendments, sample case report form) needed for the writing of CSRs are checked into the electronic archive (eg, eDMS) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (eg, heading styles, language, accuracy).

6. Proofreads, reformats and edits document text, as required, to ensure that all report appendices meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing. Reviews and performs QC checks of all documents and appendices to ensure consistency between and within documents.

7. Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.

8. Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary.

Minimum Requirements 1. Bachelor's degree or equivalent with at least 2-3 years of experience the

pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles.

2. The incumbent should have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (eg ICH, FDA, EMEA).

3. The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards.

4. The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.

5. The incumbent must be a skilled user of word processing applications. ************************************************************************* Contact If interested, contact: Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing T: 215-536-6979 F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com Medical Writer – Hopewell, NJ

Position is 6-month contract. Description

1. Bachelor's degree in relevant scientific discipline with a minimum of 3-5 years in pharmaceutical industry experience.

2. Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.

3. Good understanding of the global pharmaceutical drug development process and regulatory requirements for safety risk related documents. Additional knowledge of

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regulatory guidelines preferred (eg. Good Pharmacovigilance Practice and Good Clinical Practice Guidelines).

4. Demonstrated ability to perform detail-oriented review of complex data from a broad range of therapeutic areas and scientific disciplines. Have excellent attention to detail.

5. Demonstrated strong, effective organizational, facilitation, and interpersonal skills in communicating with cross-functional teams. Communicates with clarity and consistency while impacting alignment of stakeholder activities regarding safety risk related document reporting requirements. Successful and creative negotiation of difficult compliance issues. Strong ability to resolve and communicate quality issues, and perform root cause analysis.

6. Working knowledge of a document management system and basic knowledge of the document publishing process. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learnings.

Responsibilities 1. Coordinate and verify the compliance of complex regulatory strategic safety risk related

documents and submissions, with guidelines, local regulations, procedures and/or company requirements. Proactively gather information to improve training methodologies. Identify process improvement opportunities and champion their implementation, as assigned.

2. Perform detail-oriented review of complex safety risk related documents while leveraging several pieces of source documents (eg. meeting minutes, signal log, commitment database, SharePoint, document management system). Responsible for in process reviewing and QC/proof-reading of documents prepared by staff (for e.g. cross checking sections, data points, tables, regulatory templates). Prioritize to ensure that timelines are met. Participate in the development of quality-related processes and tools. Provide support for management of quality issues. Facilitate and advise on corrections, corrective and preventive actions related to designated quality issues. Identify trending and consistency of all safety risk related documents in the department. From trended data by maintaining quality tracking, offer process improvement innovation ideas.

3. Provide advice for maintaining and performing qualitative and quantitative review and checking safety risk related documents. Maintain a familiarity with company systems and related processes. Provide quality consultancy to other personnel.

4. Ensure compliance with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with the medical writer to ensure timely completion and high quality of assigned documents. Share information in an open, balanced and objective manner with other quality management and other professionals to positive, results-orientated team environment.

5. Report findings of quality control reviews clearly and within required timeframes. Review documents and provide documentation of requirements to the lead author. Attend (or where required, lead) internal quality focused meetings. Provides training and guidance to all functional area staff members on a variety of quality topics.

*************************************************************** Contact If interested, contact: Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482. Senior Manager, Medical Writing (Oncology) San Francisco Bay Area, CA

Position is permanent. Description

1. Demonstrated ability to prepare a wide range of regulatory documents, such as clinical

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study reports and Investigator Brochures, as well as CTD summaries, pediatric investigational plans (PIPs), and regulatory responses, in-line with regulatory requirements and internal document standards

2. Contributes to other non-regulatory medical writing activities as required 3. Participates in submission teams and provides advice/guidance for optimal presentation

of data for achievement of document objectives 4. Leads document timeline/resource planning for assigned projects within the submission

team 5. Works collaboratively with functional contributors (clinical, biometrics, virology etc),

ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines

6. Performance management may be required 7. Leads the compilation of final documents and appendices coordinating clinical,

biometrics and regulatory contributions 8. Leads/contributes to development work in relation to document standards, continuing

MS template development, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing

9. Provides scientific/regulatory writing services to support clinical trial reporting as well as a wide variety of regulatory submissions

10. Works with project teams across sites to produce complex clinical documents for global regulatory submissions

11. Is able to prepare a wide variety of regulatory documents independently or with minimal supervision

12. Writes multi-study summary documents for pivotal studies 13. Writes sections of product approval applications and other submissions 14. Works with Biometrics on clinical data interpretation 15. Reviews and prepares FDA briefing packages 16. Serves as a cross-functional resource.

Responsibilities 1. Requires a BS degree and 10+ years of relevant experience within clinical R&D or

regulatory affairs such as pharmaceuticals/biotechnology 2. Candidates with advanced degrees and less than 10 years of experience may be

considered 3. 5+ years experience in a medical writing/clinical submissions environment,

directing/preparing documents for regulatory submissions 4. Can facilitate issue resolution and lead multi-functional teams with clear direction

through complex processes 5. Demonstrated success in the independent preparation of regulatory documents,

particularly at the individual study report level 6. Strong knowledge of regulatory document requirements/guidelines

*************************************************************************** Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482. Regulatory Medical Writer (Oncology) San Francisco Bay Area, CA (East Bay)

Position is permanent. Description

1. Develop/write/edit documents for clinical development as well as technical/scientific publications

2. Will work closely with internal clinical development team members as well as external collaborators, such as KOLs and external vendors

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3. Scope of documents range from pre IND through NDA 4. Provides broad medical writing and project management support for programs and

efforts of the Clinical Development group 5. Able to develop documents from scratch 6. Documents include but are not limited to briefing documents, clinical development

plans, previous human experience summaries, human pharmacology summaries, Investigator's Brochure, clinical protocols and protocol amendments, model informed consents, interim and final clinical study reports, INDs, patient narratives, and other documents that support Clinical Development

7. Authors/co-authors/edits publications (manuscripts, review articles, abstracts, poster and presentations, etc.)

8. Performs literature searches/reviews as necessary to obtain background information and training for document development

9. Work with document templates and support eCTD document submissions 10. Facilitates review of materials/documents to enable timely finalization of documents 11. Builds agreement cross-functionally on timelines and document management to ensure

efficient document finalization 12. Assists with development and implementation of SOPs

Requirements 1. Bachelor degree REQUIRED, PhD preferred 2. Pharmaceutical clinical/regulatory writing experience a MUST

Contact **************************************************** Contact Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482. Regulatory Medical Writer (Infectious Disease) Boston, MA (Downtown)

Position is contract. Our client is looking for a medical writer who has experience writing protocols, Investigator Brochures, and Clinical Study Reports. Infectious Disease experience is required. The candidate must be on site at least 50% of the time. ******************************************************* Posted by Tamoy Kim, Recruiter at PROVEN, Inc. email Tamoy Kim at tkim@proveninc.com with your resume or referrals. Searching for Process Science Scientist, for Pharma in Irvine, CA Must have 5+ years of Downstream Process Development experience. Position will be leading group to design novel purification processes for monoclonal antibodies. Must have PhD. *********************************************************

Jobs That Crossed My Desk Through Feb. 9, 2013 ***************************************************** Posted by Jennifer Harvey, HR Business Partner at Veracyte Client Services Specialist Now hiring: Client Services Specialist http://www.ziprecruiter.com/job/Client-Services-Specialist/be42a8fa/?source=social-linkedin-group-jobs

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___________________________________________ Medical Billing Specialist - Temp Position Now hiring: Medical Billing Specialist - Temp Position http://www.ziprecruiter.com/job/Medical-Billing-Specialist-Temp-Position/0bff4c8d/?source=social-linkedin-group-jobs _______________________________________________________ Customer Care Specialist Now hiring: Customer Care Specialist http://www.ziprecruiter.com/job/Customer-Care-Specialist/be42a8fa/?source=social-linkedin-group-jobs *********************************************************** Sr. Accountant needed, San Jose -- Medical Device Please contact Jon@xcelgroup.com Jonathan Taylor Director, Finance and Accounting Search The Xcel Group, San Mateo www.linkedin.com/in/jonxcel (650) 572-0123 x222 I have a new Sr. Accountant opportunity with a medical device company in San Jose. Can you think of anyone who might be interested? They would like someone with QAD if possible. Thank you! Sr. Accountant, San Jose, Medical Device Temp to perm opportunity

The Senior Accountant is responsible for accounts payable, employee expense reimbursements, payroll, fixed assets, accounts receivable, credit and collections, banking, insurance, taxes, general ledger and financial statements. The Senior Accountant ensures that the accounting transactions in these areas are performed in a controlled, timely and accurate manner. This person may also work on a variety of special projects as an individual contributor.

********************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=4836123&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3NUTJYcf_H-lA1 Sr. Sales Associate -- San Francisco Bay Area BioSurplus- San Francisco Bay Area Job Description BioSurplus is currently seeking to hire a Senior Sales Associate for its Bay Area location. Phone interviews for this South San Francisco position are taking place now. The Senior Sales Associate is responsible to close a sufficient amount of leads to meet the company’s yearly sales goals. Utilizing his/her specialized knowledge and skills, the Senior Sales Associate shall exercise discretion with limited supervision to work with potential customers of the company’s equipment and negotiate and close sales. This position will work with a variety of internal and external stakeholders to achieve department, company and personal goals. Only people with proven sales experience need apply. SCOPE AND RESPONSIBILITIES

1. Talking to customers on the phone and in the show room with success at turning those inquires into sales with no supervision required.

2. Effectively communicating the company’s value proposition both verbally in person, over the phone, and in written communications.

3. Diligently following up on all sales leads to increase likelihood of close. 4. Providing assistance to product marketing to assure proper pricing of all equipment to

maximize sales proceeds and minimize time held in inventory

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5. Using sufficient instructive selling skills to minimize return of equipment by customers. Desired Skills & Experience EXPERIENCE / SKILL REQUIRED

1. Requires advanced scientific degree and/or work experience equivalent to a Masters level understanding of laboratory equipment.

2. Deep understanding of a range of scientific equipment to provide a consultative approach for scientific customers and make recommendations based on their needs.

3. Flexible and able to manage his/her time with daily changes in priorities that result from inbound sales opportunities.

4. Confident, organized, and enthusiastic about the company’s equipment. 5. Ability to establish rapport with a wide variety of people. 6. Able to work well in an independent environment and held accountable for personal

performance. 7. Able to exercise discretion and independent judgment with limited supervision. 8. Strong closer.

Company Description BioSurplus is a leading provider of equipment management solutions and pre-owned scientific instruments to the life sciences industry. BioSurplus offers an array of equipment management and valuation services, utilizing its proprietary methodology to assist companies during corporate M&A, upsizing, downsizing, and liquidation transition periods. Founded in 2003, BioSurplus offers solutions for every stage of the laboratory equipment life cycle — from buying to selling — and managing every process in between. We offer services nationally, internationally and sell equipment worldwide. BioSurplus is headquartered in San Diego, CA, with additional showroom / warehouse facilities located in the San Francisco Bay Area and Boston, MA. Additional Information Posted:February 9, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales Industries:Biotechnology Compensation:Salary plus bonus Job ID:4836123 ******************************************************* Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Sr. QC Microbiologist (Hayward) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Sr. Quality Control Microbiologist to work for a leading Bay Area biotechnology company. Sr. Quality Control Microbiologist Position Description: Perform as a senior level lead in a quality environment Ensure documentation and auditing are performed for quality system procedures Perform failure investigations and corrective actions Schedule or perform maintenance and calibrations on equipment Assess products for meeting quality standards utilizing microbiology and molecular biology techniques

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Operate lab instruments and software for data collection and analysis Oversee design control, verification, and product validation Preparation, review, approval and improvement of documentation for manufacturing and quality control Ability to participate in audits internally and externally Requirements: Bachelor’s degree in Microbiology, Molecular Biology; or related life science discipline with microbiology experience Minimum 4 years of related experience in Microbiology or Molecular Biology with significant knowledge of quality control operations Familiar with cGMP and ISO Familiarity with the preparation of published documents such as Certificate of Analysis and MSDS’s. Computer experience with MS office and ERP systems. Contact cheryl@biophaseinc.com if interested! Local candidates only will be considered at this time. If you are not local but plan to relocate, please let us know. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. **************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4832061&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3JyepotBbA-lA1 Associate Director Pharmanet-i3(Formerly MedFocus)- Bay Area (Greater Los Angeles Area) Job Description Member of the assigned Study Team • Facilitates weekly Study Team Meetings, including setting and circulating agendas, seeking team inputs on upcoming agenda items, taking meeting minutes/notes, drafting and circulating meeting minutes/notes, and identifying/logging/ensuring resolution of issues • Facilitates in all operational activities pertaining to the execution of clinical trials • Serves as primary contact for Exelixis functional area representatives and is responsible as the primary contact with the CRO in managing protocol execution • Maintains regular internal contact with relevant departments such as Clinical Development, Clinical Sceince, Clinical Supplies, Regulatory Affairs, Drug Safety and others as necessary. • Responsible for the day-to-day interaction with CROs in the execution of ongoing clinical trials • Assists in the creation and review of study protocols, informed consents, case report forms, clinical study reports, study materials and monitoring tools. • Establishes study milestones and ensures accurate tracking and reporting of study metrics • Ensures accuracy and timeliness of vendor and site payments, through invoice review and approval • Prepares and tracks required documentation from clinical sites. • Reviews and resolves discrepancies in clinical data with responsible CRO and clinical sites. • Reviews monitoring reports, study invoices (Vendor, Site), tracks study progress, provides updates to Managers, Clinical Operations and maintains study files. • Updates Clinical Trial Management System (CTMS), and ensures completion of systems and tools to enable successful trial execution and reporting • Assurance of regulatory compliance of investigational sites with company SOPs, FDA and ICH

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guidelines. • Creates and manages clinical trial budgets, in conjunction with Development Outsourcing • Provides input for definition of new or revised process development, problem solving, training, etc., as needed. • In conjunction with CRO, monitors will conduct initiation, routine site visits, and close-out visits. • Travel is required in the United States up to 20% in support of CRO activities Desired Skills & Experience This is a PERM opportunity. Must have 10+years Pharmanet-i3(Formerly MedFocus) Additional Information Posted:February 8, 2013 Type:Full-time Experience:Director Functions:Other Industries:Pharmaceuticals, Biotechnology Job ID:4832061 ********************************************* Please send your resume directly to: mmarinas@pharmascent.com **not for you but you know someone? Spread the word and you can earn a great referral bonus! Sr. Biostatistician - San Francisco Bay Area PharmAscent- San Francisco Bay Area Job Description PharmAscent is now recruiting for a Sr. Biostatistician in the greater Bay Area! PHARMA SR. BIOSTATISTICIAN BAY AREA (NORTHERN CALIFORNIA) The Senior Biostatistician will be responsible for developing statistical methods sections of protocols and review case report forms (CRFs). Will be involved in preparing analysis plans and write specifications for analysis files, consistency checks, tables, and figures. Will also communicate with clients regarding study protocol or statistical analysis issues as they arise; communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Sr. Biostatistician will interpret analyses and write statistical sections of study reports. RESPONSIBILITIES • Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis. • Perform protocol development, sample size calculation, protocol and CRF review. • Advise data management staff on database design, validation checks and critical data. • Write statistical sections of integrated reports. • Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data). • Fulfill the Lead role for single complex studies or groups of studies. • Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies.

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• Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings. • Manage customer relationships and provide training and guidance to lower level and new staff. Desired Skills & Experience QUALIFICATIONS • PhD or educational equivalent in biostatistics or related field and 1 year relevant experience; Master's degree or educational equivalent in biostatistics or related field and 3 years relevant experience • Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials • Strong working knowledge of SAS computing package • Familiarity with other statistical computing packages such as S+, SUDAAN, StatXact • Pharmaceutical, drug development, biotech or CRO industry experience • Excellent written and oral communication skills including grammatical/technical writing skills • Excellent attention and accuracy with details • Strong individual initiative, organization skills and multi-tasking ability. • Ability to lead and co-ordinate small teams Company Description ***PharmAscent specializes in contract staffing, contract to hire, direct hire search and small project consulting services for the FDA-regulated industries. Our team has over 40 years of combined experience in identifying top notch professionals for direct hire and contract staffing needs. We understand that “people” are the key to a successful organization. Our goal is to deliver innovative people through proven best practices and effective resource optimization. Best, Madelene Marinas Sr. Clinical Research Recruiter PharmAscent Direct: 925-627-4916 mmarinas@pharmascent.com Feel free to visit us at... www.pharmascent.com Additional Information Posted:February 8, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Referral Bonus:$500!! Job ID:4835801 ************************************* Posted by Amanda Rosales, Recruiter at SMR Group Ltd Email resume to alan@smrgroupltd.com Looking for specialty pharma reps w/ demonstrable over quota sales success in San Jose, CA, Sacramento, CA, Indianapolis, IN, Arlington, VA, Denver, CO, Portland, OR, Albuquerque, TX-NM _____________________________________________ Looking for primary care reps w/ demonstrable over quota sales success in South Bend, IN, Norwich, CT & Orange, CA. Email resume to alan@smrgroupltd.com *******************************************

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Please contact Kristina Olaussen at kolaussen@proveninc.com or 858-412-1108 for additional information. Environmental Monitoring Technician - Orange County, CA PROVEN's Scientific Division is currently assisting our client, a contract manufacturing organization located in Orange County, CA to identify an Environmental Monitoring Technician. The Environmental Monitoring technician will perform Environmental Monitoring (EM) and laboratory testing functions that are the responsibility of the Quality Control Microbiology lab. Duties include: Monitoring of cleanrooms including viable and non-viable air testing, surface microbial sampling, temperatures, pressure differentials and collection of purified water/steam samples throughout the manufacturing facility. Performing colony counts of EM sample plates/strips Conductivity and TOC analysis of water samples. Bioburden testing of water and various manufacturing samples using filtration and/or spread plate method within a laminar flow hood Gram staining of recovered organisms Growth promotion testing of microbiological media Analyst is required to adhere to gowning requirements for the areas being monitored. This position requires strict adherence to written Standard Operating Procedures, Test Methods, Good Manufacturing Practices and Good Documentation Practices. This includes careful attention to detail and accurately recording all information related to testing. QUALIFICATIONS: Bachelor’s Degree preferably in a biological science or minimum of two years experience and/or training; or equivalent combination of education and experience. The individual must have a basic knowledge of laboratory procedures and aseptic technique. They should be familiar with requirements related to manufacturing in a cleanroom environment. Must be able to work well with and support the others in the QC Micro group to schedule and complete tasks on time, while remaining flexible in the event of changing manufacturing schedules and processes. Good cooperation and teamwork are essential. Ability to effectively interact with manufacturing and other company personnel in order to effectively monitor areas with minimal disruption to manufacturing processes. Availability to work overtime and/or weekends when necessary. Basic computer skills including e-mail, word processing and spreadsheet programs. Basic mathematical skills including addition, subtraction, multiplication and division, fractions, decimals and exponential notation. *************************************************** Posted by Jeanne Miller, Talent Acquisition and Management Contact and see details at http://bull.hn/l/109Q5/4 Exceptional position with progressive biopharmaceutical company in Orange County, CA! Now Hiring: Scientist, Process Science in Irvine, CA Exceptional Process Science career opportunity in Orange County, CA with a clinical stage biopharmaceutical company focused on the treatment and diagnosis of cancer. Responsibilities include collaboration with Process Science and Manufacturing departments to design, optimize

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and scale downstream processes for mAb development and transfer to manufacturing. Design and execution of well-controlled experiments, compiling, analyzing and reporting results in a clear and concise fashion. Participation in departmental meetings, providing results and key learning in updates to the entire Process Science team. Regularly participate in conferences and journal publication in order to further the scientific area in which you practice. Qualifications: Ph.D. in biochemistry, chemical engineering or related discipline Minimum of 3-5 years of industrial experience Key expertise includes experience in downstream process development including one or more of the following operations: primary recovery, chromatography, nano-, micro- and tangential flow filtration Proficiency with DOE and in-process analytical assay methods (spectrophotometry, SDS-PAGE, HPLC, ELISA) is preferred Experience with radiolabeling of proteins is a plus A demonstrated ability in competent execution and recording of scientific experiments is essential, as is the ability to read and adapt methods from the scientific literature to solve problems ******************************************* Apply at: http://www.nnepharmaplan.com/en/Career/Jobs/USA/Jobs-in-USA/?vacancy- Senior Project Manager, Pharmaceutical Automation NNE Pharmaplan- San Fran, LA/Irvine or NC locations possible (San Francisco Bay Area) Job Description Do you have the opportunity of working in a startup, yet have the world class compensation, benefits and stability of a global leader? Our people do. Do you work in a company known the world over for excellence? Our people do. Do you work on the most challenging and cutting edge projects at the world’s leading pharmaceutical companies, helping to save and enhance millions of lives? Our people do. Join NNE as we continue to expand in North America and you’ll discover how we have grown from our roots at Novo Nordisk Engineering to become the world’s largest engineering consulting firm specializing in Life Sciences. Join NNE and you’ll also find that we treat our people just as we treat our customers, with the highest regard. NNE's truly world class benefits include a 9% 401k match, Base, Bonus, Flex time, 4 weeks of PTO/Vacation, 11 holidays, short and long term disability as well as comprehensive Medical, Dental and Vision coverage options at minimal cost. We are looking for 2 experienced Senior Project Managers to join our team in San Francisco, CA or in one of our offices in Morrisville, NC, Boston, MA or Southern CA. YOUR JOB: As a Senior Project Manager you should be a self-starter, who is capable of working both independently and as part of a project team. Occasionally this job will require flexibility and a willingness to travel to support projects both nationally and internationally. As a Senior Project Manager you will work on NNE Pharmaplan projects but will also be required to work inside client project teams. YOUR RESPONSIBILITIES •Provide quality engineering Project Management services to our clients in the Pharmaceutical and Biotech industries •Coordinate multi-discipline engineering projects throughout the entire life cycle - from proposal to final project handover •Create a Project Management Plan for each project

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•Manage the planning and execution of all critical success factors within the project, i.e. scope, time, cost and quality •Supervise the daily activities of the project team, including contractors and suppliers •Provide effective leadership, coaching and conflict resolution to the project team in order to meet project goals and objectives •Ensure that proper engineering procedures, methods and technical solutions are utilized throughout the project •Participate in sales activities including lead generation, presentations and proposals. •Travel locally to client sites on a regular basis; opportunity to travel nationally and internationally if desired YOUR QUALIFICATIONS: •10+ years of engineering project management experience •Experience with designing, programming and testing automation systems in a pharma/biotech manufacturing, laboratory, R&D or pilot plant environment •Engineering degree – BS and MS or equivalent experience required •PMP or IPMA project management certification preferred •Automation software experience including one or more of the following: DeltaV, iFix, iBatch, Bailey, ABB 800xA, Aspentech, PI-Historian, PLC, SCADA •Ability to manage both automation projects and multi-discipline projects •Strong networking experience with Pharmaceutical and Biotech companies preferred •Experience with qualification and validation of automation projects •Previous experience in Pharmaceutical, Biotech or Life Science industry is required •Previous ISO 9001 and cGMP quality education or training •Strong computer skills including Microsoft Office, project management, and scheduling tools •Excellent verbal and written communication skills •Ability to prioritize multiple projects and tasks •Desire and ability to travel based upon project requirements We offer employees a challenging job in a dynamic organization, where our goal is to be known for quality and for keeping our promises. Our thinking is ground-breaking and innovative and we work at being efficient in everything we do. We want to attract and retain the best possible employees by making the company an exciting and challenging work place. You will be part of a unique and ambitious team. NNE Pharmaplan is a proud to be an EOE Desired Skills & Experience Pharmaceutical Automation Project Management experience Company Description NNE Pharmaplan is the world’s leading engineering and consulting company in the complex field of pharma and biotech. They cover all segments from biopharmaceuticals and vaccines to medical devices and help customers develop, establish and improve their product manufacturing. NNE Pharmaplan employs 1,700 people at more than 30 locations around the world. They combine engagement in global health issues with a holistic approach focusing on customers’ need for total solutions. Engineering for a healthier world – is their role in an industry that improves people’s lives worldwide. To learn more about the company, please visit nnepharmaplan.com. Additional Information Posted:February 7, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Manufacturing, Consulting Industries:Biotechnology, Pharmaceuticals, Chemicals

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Compensation:6 figure base + bonus, flex, 9% 401k Job ID:4819752 ****************************************** Apply on company website Product Manager Raptor Pharmaceutical- Novato (San Francisco Bay Area) Job Description The position is responsible assisting in the development, management, and execution of marketing strategies and tactical programs to effectively achieve commercial objectives for Procysbi in nephropathic cystinosis. Manage assigned projects related to Procysbi marketing including, but not exclusively, the following areas:

Participate in the development of the annual US strategic and tactical marketing plan for Procysbi

Cultivate and maintain relationships with key customers (patients and/or physicians) Participate in the development and implementation of the US medical communication

plan Provide input and tactical assistance to the publication plans of Procysbi Assist in organizing and participate in advisory board meetings with key customers

(patient and physician) Participate in the development and management of an operating budget of the

marketing plan Obtain feedback from field force to effectively support their efforts Evaluate on a continuous basis the efficacy of communications/sales by target

audiences to make recommended changes Desired Skills & Experience The successful candidate must possess U.S. in-line pharma/biotech specialty and/or orphan marketing experience (global marketing experience is a plus) of at least 5 years. Product launch experience strongly desired. Key skills: - Self-starter and highly self-motivated. - Action oriented with strong prioritization skills - Ability to work well in highly dependent team environment - Spend effectively within budget (manage budgets) - Ability to evaluate, question, and provide recommendations constructively with appropriate assertiveness - Strong written and oral communication skills - Strong analytical skills (ability to draw insights from data) Education/Experience/Travel

Undergraduate degree in life science or marketing; MBA or M.S. or PharmD is a plus Minimum of five years of direct in-line marketing experience. Additional experience in

other areas such as field sales, district management, advertising and sales training a plus

Solid understanding of pharma/biotech marketing, product development and life-cycle management

o Travel will be approximately 20% and predominately in the US. Company Description Raptor Pharmaceuticals Inc. is a fun, growing, and professional biotech company. If you are driven to learn and succeed, please bring your list of accomplishments, sense of humor, and your dog. We'd love to meet you! Additional Information

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Posted:February 8, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Biotechnology, Pharmaceuticals Compensation:Base salary, bonus, stock options Job ID:4825184 ****************************************** Please e-mail resumes to alex.harrigan@srxsource.com if you are interested. Looking for a Regional Sales Rep to cover the Bay Area in CA calling on oncologists and rheumatologists. I have a great opportunity as a Regional Sales Representative for a specialty pharmacy covering the Bay Area in CA. I am looking for someone who has strong existing relationships with oncologists and rheumatologists within the territory. ****************************************************************** Find listings at http://bit.ly/V4TNRL Jobs in Biotech & Medical Device Companies Darshana Varia Nadkarni's Blog Jobs – February, 2013 — (Software, Hardware, Quality, Clinical) For the opportunities below, please send resume at wd_darshana at hotmail dot com. Please indicate in the email how closely the job description matches your background and identify gaps, if any. Also, indicate your current compensation and compensation expectations. Prototype Hardware/Firmware Design Engineer – SF — full time There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus. Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology. Machine Learning Specialist Requirements: Minimum 5 years experience in creating high-performance classifiers, preferably working on biological data. Deep knowledge, skills and experience in machine learning techniques, in particular for processing large databases of biological information. Should be proficient and able to design, operate and validate intelligent systems from scratch. Excellent written, verbal and teamwork skills. Highly preferred: Relevant bio experience, such as working with biological signal databases; Experience in engineering for consumer devices/services; and Python expertise. Responsibilities: Lead the development of algorithms based on the signals from our advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top

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secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into our consumer products. Digital Signal Processing Specialist – SF, CA (full-time) There is an opening for Digital Signal Processing Specialist, with excellent DSP skills to join a multi-disciplinary engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. Required Skills & Experience: Excellent skills and eagerness to expand knowledge around DSP for consumer products, the consumer health industry and wearable devices; Deep skill set and experience in DSP techniques, in particular for biological signal processing. A signal processing specialist with a minimum of 5 years experience in digital signal processing, preferably including experience relating to biological data; Proficiency in common DSP techniques including adaptive filters, noise cancellation and pattern recognition. Preferred skills include: Experience in algorithm development based on physiological parameters such as heart rate, temperature, GSR or body motion; Experience working with optical sensing technologies and engineering for consumer devices; and Python expertise. Responsibilities: Lead the development of algorithms based on the signals from existing advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into consumer products. Software Developer with Cloud Experience – Detroit, MI (12 mo. contract opportunity) This position requires at least 2 years of experience with RedHat products in “cloud” (Cloud computing is the use of computing resources (hardware and software that are delivered as a service over a network) typically the internet. Responsibilities: *Help build out a new Red Hat Enterprise Linux/JBoss set of capabilities and applications. This role will help with JBoss EAP configuration through tooling Production, QA and Dev environment builds. *Part of a small team responsible for migrating to Java, JBoss, Linux platform from Weblogic and Sun Solaris. *Design and assist in building new capability architecture Skills: *Experience with RedHat Enterprise Linux platform (RHEL) *Thorough understanding of the entire Web Technology Stack *Experience in Java environments running on JBoss EAP in High Availability configurations. *Experience with “JON” – JBoss Operations Network *Experience scaling virtual web infrastructure. *Excellent scripting skills in bash, python, perl, ruby, or like languages. *Experience with agile and DevOps methodologies and philosophies. *Experience with automated provisioning solutions, particularly OpsCode Chef. *Comfortable in UNIX command line environments. *Experience with webservices and enterprise level web applications *Experience with rapid release software development practices (Agile/Scrum) *Solid understanding of testing components and deliverables within the Software Development Life Cycle (SDLC) Education: Bachelor’s degree in computer science or equivalent Quality Engineer – Plastic medical device contract manufacturing company – Gilroy, CA details coming soon………. Guidewire Developer: Washington DC Required Knowledge, Skills & Experience: Experience with Guidewire application integration or alternatively, 3 or more years experience to include the following – Web developer with strong knowledge of Java, JavaScript, JSP, HTML, XML, and SQL Server 2000/DB2, Spring web services, Industry standard development tools, preferably IntelliJ System Development Methodology, tools, and techniques experience Property and Casualty Insurance industry

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experience Experience working as a part of an Agile development team. Also Preferred – Experience with Enterprise Service Bus (ESB) technology, preferably Oracle Fusion Middleware. Essential Functions include: Estimating effort required for each integration point, Designing the overall integration architecture in conjunction with experts in target systems, Designing and coding integration programs including plug-ins, message sinks (and supporting business rules), and programs that call the Guidewire application APIs, Setting up and managing automated build and testing processes (if included in project scope), Resolving issues identified in testing. C, C++ & MQ Software Engineer Opportunity – Boston There is an immediate opportunity for software engineer with 5+ years experience in C/C++ and MQ, at Boston location. Some exposure to Java is required. Job function involves MQ setup, configuration work, but primary requirement is experience with C/C++ coding for business logic and use C/C++ MQ libraries to talk to MQ. When sending a resume (as an attachment), please indicate in the email how closely your experience matches the description above and where the gaps are. Also, please indicate your compensation expectations. Clinical Data Manager – Medical Device Company — San Carlos, CA There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System. Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices. HP Extream Architect – LA: 12 month contract opportunity with insurance client This opportunity requires 12+yrs experience in software architecting with Java platform and content management, including output management. Experience as a Technical Architect and provided advisory services around technical architecture and design. Should be able to design applications which leverage BPM and SOA tools along with CCM Tools. Also required, knowledge of BPM and SOA tools and knowledge of Portals and Content Management systems. Good understanding of Insurance domain, preferred. Job functions include: Analyze the requirements, technical design and documentation and accordingly raise queries and provide critical inputs; Undertake Solution Design, Technical Architecture and Design of Dialog Applications; Work in Business transformation projects; Handle Pre-Sales and Estimation and Engagement Design for the CCM Practice; Undertake development of new templates; Create new builds and action amendments using HP Exstream; Define Migration Strategy to HP Exstream from other CCM tools like Documerge; Experienced Roadmap visualization and roll out planning and strategizing; Create builds, Supervise Unit Testing and System Testing; Testing and troubleshooting as well as documentation of designs; Train and Groom a team on HP Exstream and bring them to speed; Work with Client and Internal Stakeholders to manage timelines, critical KPIs and deliverables to the client during the course of project; Help in identifying testing procedures and define development standards for performing CCM Application Development on products like Oracle Documaker,Thunderhead, HP Exstream, Papyrus, Doc1 etc. Clinical Study Manager – CO — requires Medical Device Clinical Study Management Experience, preferably with cardiac valve devices

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******************************************** Apply at Real Staffing Document Control Specialist Real Staffing Group- San Francisco Bay Area Job Description Document Control Specialist A medical device company in the Sunnyvale, CA area is looking for a Document Control Specialist to join their team. This is a contract-to-hire role and excellent opportunity to join a start-up organization who just received funding and is going through a growth phase. The Document Control Specialist will be responsible for doing doc control, physical filling, reviewing records, reviewing redlines, and inspecting parts with 10-guages and calipers. Document Control Specialist Requirements:

1-3 years document control experience Proficient in Microsoft Office Medical device industry experience preferred Solid labs experience preferred

If you are interested in this position, please apply to this job posting at your earliest convenience. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants.

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As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:February 7, 2013 Type:Contract Experience:Director Functions:Science Industries:Pharmaceuticals Job ID:4823858 ______________________________________________________ Associate Director, Drug Safety Scientist Real Staffing Group- San Francisco Bay Area Job Description Associate Director, Drug Safety Scientist A pharmaceutical company in South San Francisco is looking for an Associate Director, Drug Safety to join their team. Associate Director, Drug Safety Scientist Responsibilities:

Interprets, evaluates, and analyses individual case safety reports Interprets, evaluates, and analyses aggregate safety data Develops written safety data analyses Develops signal detection and recommends actions Participates in risk management activities Recommends product labeling changes based on review and analysis of safety data Responds to regulatory authority inquiries Assists with special projects Provides scientific expertise and oversight Participates in recruitment and selection of additional personnel Ensures compliance with business agreements and regulatory requirements Is a liaison with business partners, vendors and regulatory authorities Mentors internal resources Trains external audiences Serves as project lead for assigned projects Develops department policies and guidelines

Desired Skills & Experience Associate Director, Drug Safety Scientist Requirements: General Skills

Experience with computer based applications (e.g., Microsoft Word, Excel, PowerPoint) Detail oriented Excellent interpersonal and organizational skills Excellent written and verbal communication skills Ability to work proactively Excellent problem solving skills

Specific Skills Knowledge of and ability to interpret and apply international safety regulations Demonstrated competence in collecting, analyzing, and reporting safety data in

compliance with regulations Experience preparing investigational and postmarketing regulatory reports Experience developing data analyses and medical evaluation of safety data

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Experience with pharmacovigilance related computer systems and programs Experience managing people and teams Excellent leadership skills

Education & Experience RN/MS, PharmD, MD with 5+ years pharmacovigilance experience

If you are interested in applying to this role, please respond to this job posting ASAP to be considered. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:February 7, 2013 Type:Contract Experience:Director Functions:Science Industries:Pharmaceuticals Job ID:4822461

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____________________________________________________ Sr. Director/Director Drug Safety Real Staffing Group- San Francisco Bay Area Job Description Senior Director / Director, Drug Safety A pharmaceutical company in the Berkeley, CA area is looking for a Senior Director/Director, Drug Safety to join their team. This is an exciting opportunity to join a growing company. Senior Director Drug Safety Responsibilities:

Oversees the interpretation, evaluation, and analysis of individual case safety reports Oversees the interpretation, evaluation, and analysis of analyze aggregate safety data Oversees development of written safety data analyses Oversees signal detection and recommends actions Participates in risk management activities Recommends product labeling changes based on review and analysis of safety data Responds to regulatory authority inquiries Assists with special projects Provides scientific expertise and oversight Participates in recruitment and selection of additional personnel Ensures compliance with business agreements and regulatory requirements Is a liaison with business partners, vendors and regulatory authorities Mentors internal resources Trains external audiences Serves as project lead for assigned projects Develops department policies and guidelines Manages personnel Aligns internal resources with projects and work load Sets internal team priorities Works with management team to set performance expectations and goals for personnel Provides on-going feedback to employees, and documents feedback Fosters teamwork and collaboration Communicates information in to the team Ensures team members have access to tools and resources Demonstrates accessibility and availability to all team members Works with personnel to plan and implement their career development Participates in budget development

Desired Skills & Experience Senior Director Drug Safety Requirements: General Skills

Experience with computer based applications (e.g., Microsoft Word, Excel, PowerPoint) Detail oriented Excellent interpersonal and organizational skills Excellent written and verbal communication skills Ability to work proactively Excellent problem solving skills

Specific Skills Knowledge of and ability to interpret and apply international safety regulations Demonstrated competence in collecting, analyzing, and reporting safety data in

compliance with regulations Experience preparing investigational and postmarketing regulatory reports Experience developing data analyses and medical evaluation of safety data Experience with pharmacovigilance related computer systems and programs Experience managing people and teams Excellent leadership skills

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Willingness to mentor others Education & Experience

MD with 8+ years pharmacovigilance experience If you are interested in applying to this role, please respond this job posting with an updated version of your resume at your earliest convenience as we are looking to identify a candidate immediately. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:February 7, 2013 Type:Contract Experience:Director Functions:Science Industries:Pharmaceuticals Job ID:4822487 ***********************************

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To Apply Please submit your resume to jobs@hyperiontx.com quoting job reference 13005-LIN in the subject line of your resume. Principals only please. Senior Director of Financial Planning & Analysis Hyperion Therapeutics, Inc.- South San Francisco (San Francisco Bay Area) Job Description We seek to recruit a Senior Director of Financial Planning & Analysis to join our growing team. Position Overview: This position will be responsible for the overall design and execution of Hyperion’s financial planning and analysis. This individual will be responsible for coordinating short and long term corporate planning processes within Hyperion including budgeting, forecasting and long-range strategic planning as well as corporate reporting efforts. Additionally, the role will be a key financial representative for strategic analysis and business development opportunities. Reporting Relationships: This position reports to the Vice President, Finance and partners with the CFO and other members of the management team. Essential Duties and Responsibilities: - Lead and coordinate the development of all corporate financial planning including quarterly forecasts, annual budget, and 3-7 Year Strategic Plans - Leads and project manages implementation of new financial reporting and planning tools; maintain tool to provide fast, reliable and informative data for management decision-making - Provides detailed month-to-date, quarter-to-date, and year-to-date financial analysis, management reporting, and financial summaries for both internal and external purposes - Prepare monthly internal management reporting packages for senior management, which include key metrics that will be used to monitor the Company’s performance - Develop dashboard to track and report key corporate metrics - Review sales commission and incentive calculations for completeness and accuracy - Develop financial models and analysis of various opportunities including licensing, partnerships, alliances, acquisitions, etc.; analyze complex financial information to provide recommendations to senior management - Work on special projects and provide other analyses as directed Desired Skills & Experience Requirements: - Bachelor’s degree in Finance or Accounting required (MBA or CPA preferred) - At least eight years of applicable financial, planning, and analysis experience - Experience in life sciences companies with commercial operations preferred - Outstanding analytical skills - Demonstrated record of career progression - Advanced Excel and financial modeling experience - ERP system experience - Strong knowledge of US GAAP accounting and financial principles - Excellent oral and written communication skills - Strong collaboration and interpersonal skills - Self starter with ability to prioritize and balance multiple tasks, cope with multiple deadlines, dynamically changing environment, and work under pressure Company Description Hyperion Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of orphan diseases and hepatology. We are an Equal Opportunities Employer.

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Hyperion Therapeutics, Inc.Additional Information Posted:February 8, 2013 Type:Full-time Experience:Director Functions:Finance Industries:Pharmaceuticals, Biotechnology Job ID:4824593 ************************************************** Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Contact cheryl@biophaseinc.com if interested! Reagent Chemists BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for Reagent Chemists to work for a leading Bay Area biotechnology company. Reagent Chemists (multiple openings) We are recruiting for multiple immediate openings in Reagent Chemistry for our client located in Santa Clara. These positions are temporary for 6 months. In this role, you will be working with the manufacture of reagent products that are used in biotechnology manufacturing of medical diagnostic kits. We are seeking self-starters with relevant experience to be able to hit the ground running. Responsibilities: Manufacturing products utilized in kits including reagents from raw materials to bottled and labeled finished goods. Master plate coating equipment Process and testing Formulation of reagents Requirements: Bachelor’s degree in life sciences with 2-5 years of industry experience in medical diagnostics production or development preferred Either of the following: Experience with ELISA in a relevant setting is required; Experience with cell products, antibodies, protein purification and conjugation and ELISA Experience in GMP and ISO Ability to troubleshoot and test product Mechanical ability for equipment set-up Strong math skills Excellent oral and written communication Organizational abilities, attention to detail and strong interpersonal skills Ability to function in a regulated and highly documented environment Local candidates only will be considered at this time. If you are not local but plan to relocate, please let us know. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities.

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Also, connect with us: LinkedIn: http://www.linkedin.com/groupRegistration?gid=1823879 ************************************* Please contact clyons@compasscgroup.com to be considered. Posted by Charley Lyons, Sales and Recruiting Manager for the Compass Consulting Group BioPharma Market Researchers needed for permanent and consultant based projects! We are filling permanent openings and consultant based projects for our Biotech & Pharmaceutical clients in Los Angeles & San Francisco bay areas. Those with Primary market research, Secondary market research, Competitive Intelligence, Forecasting, Analytics, etc. ********************************************************************************************** Posted by Brannon Owens, Director, Staffing at Allied Search Partners To apply: Please send resume to Brannon@alliedsearchpartners.com or fax to 888 388 7572. No other information about the location or name of facility is given at this time. Please Note: We are a staffing agency and conduct searches confidentially for our clients either at their request or to protect our resources involved in locating talent. In order to facilitate this we must submit a resume to HR. Your resume will only be sent over for the position in this job description Our job is to connect talented individuals such as your self with top notch labs Full disclosure will be given once HR has requested an interview We do not send your information to current or past employers nor do we send your information to anywhere you request that it not be sent Site Director of Clinical Research needed for full time opportunity near Santa Rosa, CA. Interested candidates should submit an updated resume to Brannon@alliedsearchpartners.com for review. Are you a good fit for this job? Site Director of Clinical Research in Santa Rosa, CA Allied Search Partners, the leaders in the permanent staffing of Laboratory/Biotech and Biopharma professionals is currently conducting a search for a Site Director of Research Site. Know someone for this position? We offer a $$ bonus if we place your referral in a position. For a complete list of current Allied Search Partners openings Nationwide please go to: http://www.alliedsearchpartners.com/careers.php Position Title: Site Director of Clinical Research Location: Santa Rosa, CA Relocation Assistance: No

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Schedule: Full Time/Permanent Summary Financial reporting, fiscal management, study operations, patient recruitment, medical partnering, regulatory, QC, budgets, personnel and site administration. Primary Job Responsibilities: Staff Management and Leadership - Builds and motivates site personnel; allocates resources to studies; hires and assures adequate staff training and orientation to new processes; conducts staff evaluations and issues disciplinary actions Study Oversight - Provides oversight and guidance in the conduction of all clinical trials at the site Financial Accountability - Assists in establishing and managing to the annual budget for the site; ensures timely data entry of study budget information and subject activity into revenue recognition system; assists corporate Contracts & Budgets department with study budget analyses. Patient Recruitment/Retention - Responsible for achieving recruitment and retention goals Business Development and Sponsor Relations - Actively seeks new studies for the site and our organization; ensures sponsor needs are met on active studies Medical Partner and Vendor Relationships - Assists the Medical Director or PI, if applicable, in the recruiting, training and managing of medical partners and vendors to expand the therapeutic capabilities of the site Facilities Management - Maintains facility operations in top working order in preparation for sponsor qualification visits and audits; manages all clinical research supplies to ensure adequate supplies are available for all studies Strategic Growth - Assists the Regional Director in the development and implementation of strategic and tactical plans ... http://bull.hn/l/1037T/6 ********************************************* Started by Jon Hauptman, President, The Hauptman Group Healthcare Search Consultants APPLY DIRECT at www.thehauptmangroup.com http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=211715298&gid=61852&trk=eml-anet_dig-b_nd-pst_ttle-cn&ut=3HPBjutClQXBA1 Specialty Pharma Rep (Pain) Positions - Bakersfield, Phoenix, San Diego, Valencia! STRONG specialty pharmaceutical organization is looking for a proven "go-getter" who has a consistent track record of success within the pain management (pharma) arena. Must Have QUALIFICATIONS:

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4-Year Degree 3+ Yrs Pharma Sales Relationships w/ Pain Management and/or Orthopedics preferred Decorated with Documented Track Record of Exceeding Sales Quota Top Performers, only! No job hoppers. Salary + Bonus : $100k - $130k Great Benefits: Car, Medical, Dental, GREAT 401k, etc.. Specialty Pharma Rep (Pain) _ San Diegopcrecruiter.net *************************************** Apply on Real Staffing website http://www.linkedin.com/jobs?viewJob=&jobId=4812551&trk=eml-anet_dig-b_premjb-ttl-cn&ut=0P8T_-_nBjXBA1 Drug Safety Manager Real Staffing Group- San Francisco Bay Area Job Description Drug Safety Manager The Drug Safety Manager will support the client Drug Safety Department as an interdepartmental project lead in the handling and analyses of safety data from clinical trials and spontaneous post-marketing reports. The Manager will work closely with the assigned project lead to facilitate and meet client project deadlines. This will include such activities as oversight and management of Drug Safety Associate staff, ensuring timely reporting of SAEs to Regulatory Authorities and cross-reporting to pharmaceutical partner(s). The Project Manager will also ensure that all adverse event information is handled in a manner consistent with departmental standard operating procedures as well as federal and international regulations. The Drug Safety Manager will also participate in development, implementation and maintenance of quality systems for all Drug Safety activities, encompassing processes, procedures, compliance and metrics; additionally, the Manager will support the management of other employees with a working knowledge of employee policies and procedures. Drug Safety Manager Responsibilities: The major duties and responsibilities will include but are not limited to the following:

Oversee individual projects as assigned within the client drug safety setting Provide directional support to Drug Safety Associate staff Draw on knowledge of Drug Safety, disease specific clinical knowledge and

understanding of the companies objectives to solve complex problems in creative and effective ways, as well as to anticipate routine problems and mitigate them without supervisory intervention

Maintain a high level of understanding of federal and international regulations and guidances in order to guide departmental policies and procedures

Provide guidance and mentoring when appropriate to other team members in the performance of their job, including day to day case processing activities

Evaluate project case workflow and offer solutions for process improvement Maintain regulatory and department compliance by ensuring timely completion of client

reports and facilitating submissions of reportable cases to regulatory agencies, study investigators, licensing partners and CROs

Participate in the preparation of client aggregate safety reports such as Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), quarterly safety reports to Ethics Committees, and annual reports to regulatory authorities

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Process SAE and AE reports of client marketed and investigational products in accordance with all applicable regulations, guidelines including client Safety Management Plans, and SOPs with little or no supervision. This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check

·Conduct periodic reconciliation of SAEs between the client drug safety and clinical trial databases for ongoing clinical studies

·Represent the Drug Safety Department in client cross-functional team meetings Draft and update client and company departmental SOPs and other work practices as

assigned to be consistent with regulatory guidelines and good pharmacovigilance practices. Participate in regular audits of department SOPs

Draft drug safety documents, such as client Safety Management Plans for client clinical studies or postmarketed products, and development of various forms as required, such as Clinical Study Reporting Forms

Maintain an awareness of allocated project resource utilization and make appropriate recommendations to company project lead as required

·Participate in training of drug safety staff and internal and external client audiences on drug safety related topics, such as investigator meetings as required

Desired Skills & Experience Drug Safety Manager Requirements:

Typically requires a BS degree in a life science discipline, e.g., pharmacy, nursing, and a minimum of 6 years of relevant experience which includes 4 years in drug safety

Broad knowledge of domestic and international drug safety regulations, industry practices and standards

Working knowledge with at least one major safety database system (e.g., Argus, ARIS-g, Oracle AERS, E-Trace)

Strong attention to detail, teamwork and initiative Excellent written and oral communication skills, resourcefulness and personal

organization skills Excellent working knowledge of MedDRA and WHODRUG coding dictionaries. Proficient in Microsoft Word, Power Point, and Excel; experience with Microsoft Visio

helpful Strong interest in managing people and projects

If you are interested in applying to this role, please respond to this job posting ASAP as we are looking to fill this position immediately. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector.

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Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:February 6, 2013 Type:Contract Experience:Mid-Senior level Functions:Science Industries:Pharmaceuticals Job ID:4812551 ________________________________________ http://www.linkedin.com/jobs?viewJob=&jobId=4812515&trk=eml-anet_dig-b_premjb-ttl-cn&ut=14r9JjiJFmXBA1 Senior Drug Safety Associate Real Staffing Group- San Francisco Bay Area Job Description Senior Drug Safety Associate A pharmaceutical company in South San Francisco is looking for a Senior Drug Safety Associate to join their team. This is an excellent opportunity to join a stable company with a product on the market and an exciting pipeline. The Senior Drug Safety Associate encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Responsible for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed products, while also assisting management in establishing and implementing departmental strategy. Serves as a liaison to external healthcare providers, investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Science, Clinical Operations, Biometrics, Regulatory & QA, MedSA and Commercial. Desired Skills & Experience Senior Drug Safety Associate Requirements:

3-5 years of Pharmacovigilance / Drug Safety experience or equivalent required. Both pre-approval and post-marketing experience in a global environment highly

desired. Oncology experience preferred Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations

governing both clinical trial and post-marketing safety environments Working knowledge of the overall drug development process Extensive knowledge of medical terminology and principles of clinical assessment of

adverse events in the pharmaceutical industry

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Expertise in MedDRA dictionary with relevance to adverse event coding Extensive experience with software-based drug safety systems required, preferably

ARISg Strong computer skills (MS Office)

Education/Training: Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent

If you are interested in applying for this role, please respond to this job posting ASAP in order to be considered as we are looking to fill this role immediately. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:February 6, 2013 Type:Contract Experience:Mid-Senior level Functions:Science Industries:Pharmaceuticals Job ID:4812515 *************************************************

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Apply on company website TEMPORARY REASEARCH ASSOCIATE / RESEARCH SCIENTIST - (PROTEIN) BIOCHEMISTRY Halozyme Therapeutics, Inc.- San Diego - LOCAL CANDIDATES ONLY (Greater San Diego Area) Job Description Halozyme's discovery research is a dynamic collection of very talented researchers aiming to solve challenging technical questions to propel drug discovery. This candidate will be an experienced protein biochemist who could work with minimal supervision in the New Molecular Entity group to help the development of lead therapeutic candidates to support preclinical studies. The candidate should have experience in recombinant protein expression, protein purification, protein conjugation, protein characterization and functional assay development. The position will require putting to use all available tools to develop the best protein targets for developing new therapeutic proteins, as well as identifying the most promising candidates of therapeutic potential (in collaboration with other groups at Halozyme). The candidate must be able to comprehend pertinent literature and present data in internal meetings regularly. Strong organizational and interpersonal skills are a must. The individual will be expected to demonstrate the ability to meet metric-driven time-lines, keep the laboratory in order and mentor the junior lab assistants. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These include, but are not limited to:

Strong background in Protein Chemistry. Extensive experience in bioconjugation for protein labelling ,conjugation and coupling to

solid phase via various chemical reactions. Proven hands-on experience in small scale production and purification of recombinant

proteins, and extensive affinity purification experience in antibody. Expertise in FPLC systems and chromatographic methodologies including , HIC, IEX,

SEC and RP. Skilled in analytical techniques for protein characterizations such as SDS-PAGE,

Western blot analysis and ELISA assay. Experience in assay development in different platforms such as solid phase, solution

and cell-based assays. Familiar with antibody affinity measurement and protein epitope mapping. Knowledge of protein stability and formulation methodologies is a plus.

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES: Skilled in molecular biology techniques. Knowledge of handing bio-hazard samples. Other duties as assigned.

Desired Skills & Experience EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

B.S. with 6-10 years of relevant experience, a M.S. degree with 4-8 years of experience, or a Ph.D. with 1-3 years experience in an appropriate biological discipline, with minimal 1 year of industry experience.

Ability to work in a team based environment with excellent communication skills. Position requires routine data presentation, assembly of written research reports, and

writing of manuscripts for peer reviewed publication. Proven record of peer reviewed publications. Special Training or Certification: Radioactivity and biohazard training.

TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: Software Knowledge: Windows, MS Office (Outlook, Word, Excel). INTERNAL AND EXTERNAL RELATIONSHIPS:

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Internal interactions with scientific staff within the department and across functional department areas and the organization as a whole, including executive management.

External interactions and collaborative contacts with vendors, as well as academic and industry professionals including, principal investigators, senior and executive management. and clinical researchers.

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 50lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. TRAVEL: Travel may be required up to 5% of your time. Company Description Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme’s Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche’s biological therapeutics, including Herceptin®, for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid®. The product candidates in Halozyme’s research pipeline target multiple areas of significant unmet medical need. Halozyme Therapeutics, Inc.Additional Information Posted:February 5, 2013 Type:Temporary Experience:Associate Functions:Research Industries:Biotechnology, Pharmaceuticals Job ID:4799168 ________________________________________________________________ TEMPORARY SENIOR CLINICAL RESEARCH ASSISTANT Halozyme Therapeutics, Inc.- San Diego - LOCAL CANDIDATES ONLY (Greater San Diego Area) Job Description POSITION SUMMARY: The Temporary Clinical Research Assistant, Clinical Development and Medical Affairs, is responsible for creating and maintaining the clinical Central Files and providing other related support to the activities being conducted by members of the Clinical Development and Medical Affairs department. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These include, but are not limited to:

Create, organize, and maintain the CDMA Central Files. Ensure that a hard copy of documents and reports and other essential documents (e.g.,

protocols, amended protocols, and CSRs, etc.) are filed in CDMA Central Files and scanned on the Clinical network drive on the company server.

Provide secondary review of essential documents (e.g.1572s, Investigator CVs, Financial disclosure forms, etc.) as needed.

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Create or obtain, organize and file hard copies of clinical documents for clinical trial associated with Halozyme.

Interface with clinical investigative sites to obtain, track, and file study site regulatory and other essential documents.

Organize and maintain Clinical directories and files on Clinical network drive on the company server.

Upload, save, and organize digital photographs and videographs for various trials on the Clinical network drive on the company server.

Create PDF files of documents required for various reports, such as clinical study reports (CSRs), as needed.

Perform limited data entry on an occasional basis, as needed. Create Study Binders and clinical template documents. Create study labels (e.g. drug labels) and patient/subject tools or other material as

needed. Create and maintain tracking logs. Create and maintain vendor POR and track ongoing invoices Participate in creation and review of CDMA SOPs. Maintain CDMA SOP tracking log. Assist in QC process for various clinical documents. Format documents as needed. Update and maintain CDMA protocol number tracking log. Update and maintain clinicaltrials.gov account. Create, as needed Power Point Presentations. Order and ship clinical supplies as needed. Fax, mail, and Fed Ex documents as needed. Perform responsibilities under pressure and tight timelines, with the ability to juggle

multiple concurrent projects and tasks. Demonstrate attention to detail. Demonstrate creative and effective problem solving skills. Prioritize and provide status updates of deliverables. Effectively organize and manage time. Demonstrate good communication and interpersonal skills. Comply with company objectives, policies and procedures, and quality assurance

program. Perform other duties as may be assigned. In order to fulfill the above functions:

o Assist clinical staff in their absence to field and respond to communications (e.g., phone calls, faxes, letters, or emails) as needed. respond with study investigative sites, as needed.

o Contact and correspond with study investigative sites, as needed. ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

General administrative functions as needed (mailing documents, photocopying, etc.). Other duties as assigned.

Desired Skills & Experience EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

High school level diploma required, BA/BS in one of the life sciences preferred Minimum of 1 year of experience working the clinical or medical affairs department of a

CRO, biotech, or pharmaceutical company Strong clinical background or experience preferred Knowledge of Good Clinical Practice strongly preferred Prior experience with a small entrepreneurial biotech or pharmaceutical environment is

a definite asset. TECHNICAL KNOWLEDGE REQUIRED:

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Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Software Knowledge: Windows, MS Office (Outlook, Word, Excel). INTERNAL AND EXTERNAL RELATIONSHIPS:

Reports to Management, Clinical Research and Medical Affairs. Routine interface with members of CDMA and other internal departments as needed. Interface with clinical investigative sites and other vendors as needed.

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. TRAVEL: Travel may be required up to 5% of your time Company Description Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme’s Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche’s biological therapeutics, including Herceptin®, for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid®. The product candidates in Halozyme’s research pipeline target multiple areas of significant unmet medical need. Halozyme Therapeutics, Inc.Additional Information Posted:February 5, 2013 Type:Temporary Experience:Associate Functions:Administrative Industries:Biotechnology, Pharmaceuticals Job ID:4799100 ********************************************* Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.com HIRING *** Alpha Consulting Corp. is seeking a CLINICAL SITE MONITOR for its client to work in SAN FRANCISCO/BAY AREA, CA (13-00128) REQUIREMENT #13-00128 RECRUITER: CHERYL AMBROSE JOB LOCATION: SAN FRANCISCO or BAY AREA, CA LOCAL CANDIDATES ONLY!! This is a home-based position. Position located in San Francisco or Bay Area, CA with some overnight travel to WA or Los Angeles (30-40%). May also involve early-morning meetings to accommodate East Coast staff.

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Project Description: • Perform/facilitate time-efficient pre-study initiation process • Orient site personnel to study protocol/procedures • Monitor compliance to FDA Regulations and client’s SOP • Manage study-site activities through frequent on-site visits and telephone contracts Required Skills: • Bachelor’s Degree • 5+ years’ experience This 6+ month position starts ASAP. ***************************************** Posted by Jim Deavours, President, F-O-R-T-U-N-E Personnel Consultants of Atlanta Contact Jim at jimd@fpccareers.com Senior Principal Engineer / Biopharmaceuticals – Aseptic Fill / Finish – Southern California Industry leader in the Pharmaceutical and Biopharmaceutical Industry seeks Senior Principal Engineer to lead and support projects for Aseptic Fill / Finish and Lyophilization at an expanding manufacturing site. As the Subject Matter Expert, the Senior Principal Engineer will be responsible for the design, selection, start-up and commissioning of Aseptic Fill / Finish and Lyophilization lines and equipment. He / she will also be responsible for equipment improvement and problem resolutions regarding Fill / Finish and Freeze Drying as well as managing shut down, equipment replacement and start up operations. The ideal candidate will possess a B.S. in Engineering, experience managing capital projects for Aseptic Fill / Finish in GMP / Pharmaceutical manufacturing and demonstrated expertise in supporting related equipment and processes. The Senior Principal Engineer will be a self-starter with the ability to take charge and thrive in a fast-paced environment. The company provides a success oriented work environment with highly competitive compensation and benefits. ******************************************** For additional information, please contact Kristina Olaussen at 858-412-1108 or kolaussen@proveninc.com. Bioprocess Engineer - San Diego, CA PROVEN's Scientific Team is currently assisting our client, a clinical stage biopharmaceutical company located in San Diego, to identify a Bioprocess Engineer. The company’s pipeline and technology has tremendous opportunity for continued growth of internal and partnered programs. They are well positioned to capitalize on the surge in interest in antibody drug conjugates. This position will be a key member of a dynamic fast-paced research and development organization. The successful candidate will be responsible for developing and performing fermentations for therapeutic proteins to support preclinical studies and process development, and for writing development reports, protocols, and batch records. Participation in technology transfer will also

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be required. This engineer will demonstrate strong scientific/technical and interpersonal skills as well as the ability to communicate effectively. The candidate will apply biological and engineering expertise to develop recombinant protein production processes suitable for large-scale cGMP manufacturing and acts as a mentor for those with similar or less engineering expertise, providing both technical expertise and leadership to understand potential career paths. This job may require some travel to development partners and other manufacturing sites both in and outside the US. Requirements: • PhD with a minimum of 1+ year(s) or Master's Degree with a minimum 3+ years industrial experience and a degree in Chemical Engineering or related field. • Must have hands on experience in process development utilizing bacterial production strain to produce biologics. • Knowledgeable in fermentation process scale-up and technology transfer to contract manufacturing organizations. • Must have a proven record of innovation and have the ability to apply scientific and engineering principles to solve complex problems. • A good understanding of cell physiology, metabolism, and cell biology • Ability to multitask and adapt in a fast paced environment and stay focused on project deliverables. • Work with minimum supervision in designing and executing experiments and analyzing data. Desired Experience: Knowledge of Design of Experiments (DOE) and statistical analysis of data. Working knowledge of GMPs and experience writing SOPs and batch records. Experience with downstream processing including solubilization/refold, depth filtration, column chromatography, TFF/UF. Familiarity with ELISA and RP-HPLC for titer determination. Experience with pilot scale homogenizers, continuous centrifuges & fermentors. **************************************** Clinical Project Coordinator Now hiring: Clinical Project Coordinator http://www.ziprecruiter.com/job/Clinical-Project-Coordinator/d6c54142/?source=social-linkedin-group-jobs **************************************** Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Research and Development Manager BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Research and Development Manager to work for a leading Bay Area biotechnology company. http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=2776 ************************************ For consideration of this position and other opportunities please visit our career center at: http://careers.arthrocare.com Engineer, Process Development ArthroCare Corporation Job Description Engineer, Process Development Irvine, CA ArthroCare Corporation (Nasdaq:ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops and manufactures surgical devices, instruments, and implants that strive to enhance surgical techniques as well as improve patient

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outcomes. Its devices improve many existing surgical procedures and enable new minimally invasive procedures. Many of ArthroCare's devices use its internationally patented Coblation(R) technology. This technology precisely dissolves target tissue and limits damage to surrounding healthy tissue. ArthroCare also develops surgical devices utilizing other patented technology including its OPUS(R) line of fixation products as well as re-usable surgical instruments. ArthroCare is leveraging these technologies in order to offer a comprehensive line of surgical devices to capitalize on a multi-billion dollar market opportunity across several surgical specialties, including its two core product areas consisting of Sports Medicine and Ear, Nose, and Throat as well as other areas such as spine, wound care, urology and gynecology. Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development. Summary: Design, Develop, Implement and Maintain Manufacturing Processes for assigned ArthroCare lines of products (devices). Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)

Responsible for developing and implementing new processes on new products and be the M.E. representative on development teams for designing, developing, implementing, and maintaining assembly, test, and packaging processes. Ensures that time lines, cost and quality expectations are met.

Develop new techniques for assembly and test, including test fixtures, with DOE and validating new processes, evaluate failure data from field to find root cause and implement sound engineering solutions.

Responsible for training techs and assemblers and supporting transfer of product into manufacturing facilities.

Provide accurate tracking and reporting on this activity. Provide continuous engineering support on assigned products to maintain and improve

margin, performance and quality. Work with R&D team leader to deliver acceptable documentation on product (including

but not limited to: Assembly and test fixtures, Routers, MPI, Test methods, Drawings and Specs) in a timely manner.

Participate and Manage (as required) engineering builds, verification and validation builds, and provide technical data/ report to the team leader.

Ensure compliance with ArthroCare quality system and all relevant internal procedures and policies (including but not limited to: ECN, NCR, CPR, BOM, Router, MPI/ SOP).

Work on cost reduction projects to reduce material/ process costs by defining and implementing new techniques and equipment/ fixtures for assembly and test. This may require designing fixtures and implementing in manufacturing facilities.

Assist and lead product and process transfers to Costa Rica manufacturing facility. Supervisory Responsibilities: Technicians and/ or clean room personnel as required Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Education and/or Experience:

Essential. B.S. or M.S. degree in Engineering. At least 3 years in related field. Prefer experience in medical and surgical devices, and implantable biomaterials.

Language Skills: Excellent communication skills, and problem solving skills. Ability to plan and schedule multiple projects and tasks. Fluent in Spanish a plus. Mathematical Skills: Needed for engineering position Reasoning Ability: Need to be able to make rapid and sound decisions

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Computer Skills: Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works. Certificates, Licenses, Registrations: None Other Skills and Abilities: Be able to work with people at all levels of organization and understanding of MRP and document control software. Other Qualifications: Assembly and test fixture designing skills. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job. Equal Opportunity Employer www.ArthroCare.com Requirements: Site for Posting English Required Expertise Engineering - Process Development Type of Job Full Time Work Location(s) CA - Irvine Required Years of Experience 3-5 Years *********************************** http://www.linkedin.com/jobs?viewJob=&jobId=4066832&trk=rj_em&ut=3SONPiRNABWlA1 Project Management Consultant, Life Sciences Integrated Project Management- San Francisco (San Francisco Bay Area) Job Description The Project Management Consultant is experienced in leadership, accountable for overall project implementation, and will work with clients in the life sciences field, including pharmaceutical, biotechnology, and medical devices. The Project Management Consultant is a change agent who is passionate, high energy, and results-oriented with a creative and analytical mind; is experienced with advanced project management tools and processes; and has the ability to manage critical situations. As a Project Management Consultant, your primary goals and focus will be to:

Integrate self into client environment in order to effectively lead project teams while building positive professional relationships with clients and associates.

Define project objectives, requirements, and assumptions necessary to structure a project or activity.

Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements for life sciences clients.

Develop and drive integrated project plans, aligning project tactics with project strategy.

Establish, maintain, and lead high performance project teams, serving as the project advocate within the client organization.

Lead, coordinate, facilitate, and motivate all associated project resources to gain alignment on project goals and deliverables.

Lead risk management within project teams, ensuring risks have appropriate mitigation and contingency plans.

Job Responsibilities The Project Management Consultant will spend 80-100% of the time at the client facility. In order to satisfy this requirement, travel outside the local area may be required (see "Working Conditions" listed below). The Project Management Consultant will also:

Manage projects within established scope, schedule, and budget while meeting and exceeding IPM project management standards.

Develop and document high-level strategies for accomplishing specific project objectives.

Facilitate and lead effective project meetings, manage change and conflict, and develop resource planning estimates to manage project workload and productivity.

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Support project management team members to ensure success of projects while maintaining customer service focus.

Desired Skills & Experience The ideal candidate for this Project Management Consultant position will possess the following: Required Experience and Training:

Bachelor's degree in a science or engineering discipline. Advanced degrees are a plus. Industry experience related to IPM's business offerings. 8+ years of experience in the

pharmaceutical, biotechnology, and/or medical device industries. Project management experience related to IPM's business offerings. 5+ years of

experience related to one or more of the following: product development and launch, business process optimization, technology transfer, regulatory submission and/or regulatory compliance, quality assurance, and/or alliance management projects.

Knowledge and application of a disciplined project management process (Six Sigma and Project Management Professional certifications are a plus).

Required Skills and Knowledge: Exceptional interpersonal and leadership skills to effectively communicate and build

relationships with a broad spectrum of audiences at all organizational levels. Sound technical aptitude and proven ability to grasp general knowledge of multiple

disciplines and technologies with superior computer usage skills. Strong competencies in planning, project management, and organization with the ability

to lead multiple activities and resources while maintaining a focus on quality. Solid analytical and strategic capabilities and business acumen along with demonstrated

work ethic, integrity, and professional conduct and appearance. Ability to produce and present clear, concise, and professionally written communications

and presentations. Working Conditions:

Interstate, intrastate, and international travel up to 50%. Field exposure to various manufacturing, industrial, commercial, or institutional

environments. Benefits:

100% employer-paid health, dental, and life insurance coverage for employees and their families

Annual performance bonus potential Match of employee 401(k) contributions Business development incentives Paid training and certification

Company Description Integrated Project Management (IPM) is a project management consulting firm working to help companies meet their goals faster, more efficiently, and with higher quality results. Our employees are our biggest asset and the competitive advantage that sets us apart from the rest. These values-driven, self-motivated, and highly skilled employees blend as teammates into client organizations to bring leadership, discipline, and expertise to bear on the challenge at hand. With a passion for excellence, honest and ethical conduct, and uncompromising integrity, IPM achieves high quality results and consistently exceeds its commitments to its clients. Among our accomplishments, IPM is proud to have helped R&D teams cut research time in half, getting critical medicines to patients faster; to have helped a multinational consumer products corporation emerge from bankruptcy through strategic reorganization of manufacturing operations; and to have taken the kinks out of supply chains, shrinking product time to market by as much as 75%. Multiple opportunities to assist clients with projects such as these have not only solidified IPM’s reputation as a leader in project management, but also as a premier employer in the marketplace. Such distinction has enabled IPM to grow rapidly in the last few years, earning us recognition for five consecutive years as one of Inc. Magazine’s

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5000 fastest growing private companies. We’ve also been honored with the American Business Ethics Award, recognized as a “Top Small Workplace” by The Wall Street Journal and Winning Workplaces, and we are a two-time winner of the Better Business Bureau Torch Award for Marketplace Ethics. If this sounds like the type of environment that you’ve been searching for, then come join the IPM family, and help us build on our success! Integrated Project ManagementAdditional Information Posted:February 4, 2013 Type:Full-time Experience:Mid-Senior level Functions:Consulting, Project Management Industries:Biotechnology, Medical Devices, Pharmaceuticals Employer Job ID:San Fran LS Job ID:4066832 *************************************** Go to Alexza Pharmaceuticals and submit your resume. Sr. Manufacturing Engineer- Alexza- Mountain View Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California. We are developing breakthrough therapies for the treatment of acute and intermittent medical conditions. Alexza was founded by Dr. Alejandro Zaffaroni who is one of the most successful entrepreneurs in the biomedical industry with a long list of successful start-ups to his credit, including ALZA, Affymax and Affymetrix Corporations. We have an exciting opportunity for a seasoned Manufacturing Engineer. This position will play a lead role in the manufacturing process improvement and sustainment projects at Alexza. The person will work in collaboration with manufacturing, engineering and quality team members to define and execute process improvement projects. The position will also lead process development/automation projects for the early stage products. Responsibilities: • Lead process improvement efforts using lean/six sigma methodologies to drive manufacturing efficiencies in a cGMP environment. • Troubleshoot and maintain production equipment • Write manufacturing and standard operating procedures and methods • Design and develop processes for manufacturing drug/device products using statistics based experimentation and principles of process excellence • Work with in-house groups (e.g., QA, MFG) validation and vendors to ensure regulatory and company compliance of manufacturing processes. • Monitor (e.g. SPC and OEE) the performance of processes and equipment and make recommendations for continuous improvement • Conduct product and process investigations in cGMP environment; summarize results in a presentable report format. • Lead process development efforts and scale-up of the manufacturing process for combination drug delivery / medical device products. • Work closely as part of a team with product design, research and quality groups using principles of concurrent engineering to ensure manufacturability of design Requirements Skills Required: • Excellent interpersonal skills to allow effective participation in project teams. • Self motivated person with initiative to complete tasks independently. Must be able to work

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in a dynamic, multi-tasking and cross-functional environment • Excellent oral and written communication skills. • Good understanding of manufacturing processes – hands-on experience with automated assembly/manufacturing systems in a cGMP environment. Knowledge of PLC programming and associated controls is a plus. • Working knowledge of fixtures and test equipment in a manufacturing environment. • Good understanding and use of statistical methods in experiment design and data analysis. • Able to analyze complex problems and develop solutions or approaches to resolve. • Prior experience with Pharmaceutical / Medical Device process development. • Experience with process improvement projects using industry standard methodologies such as lean/six sigma is highly desirable Education and Experience: • B.S. in Mechanical, Chemical or Materials Engineering with, 6+ years experience in manufacturing engineering or process development environment. M.S. in Mechanical, Chemical or Materials Engineering with 2-4 years experience in process and/or equipment development • Prior experience in a dynamic, fast paced start-up environment would be valuable We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. Alexza is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE ************************************** Posted by Giovanni Lauricella, Medical Device Search Consultant at The Mullings Group Please share a copy of your resume with me so that we can chat further about the opportunity and your background over the phone. You can send your resume to Giovanni@MullingsGroup.com ____________________________________________________ For more information please contact Giovanni@MullingsGroup.com with your resume Vice President of Regulatory Affairs - Vascular Products – Southern California (Neuro)Vascular medical device company based in Southern California is building their entire clinical team as they pursue numerous clinical trials both in Europe and the USA. We are looking for a Vice President of Regulatory Affairs that bring both hands-on as well as leadership skills to the table… Vice President of Regulatory Affairs should: • Be open to travel 20% • Hands-on submissions experience with Class III devices/PMA • Be able to lead a team • Have exposure to quality experiences • Be knowledgeable in the vascular space • Be willing to relocate to Southern California ************************************************************ Sr. QA Operations Associate | South San Francisco, California Apply Here - http://jobvite.com/m?3S2eHfwz Onyx Pharmaceuticals - Sr. QA Operations Associatehire.jobvite.com Sr. QA Operations Associate - The Sr. QA Associate is responsible in supporting all functional Quality Assurance activities related to the disposition of all Onyx finished products for use as clinical trial material. *******************************************************

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Posted by Jennifer Harvey, HR Business Partner at Veracyte Clinical Trials Manager Now hiring: Clinical Trials Manager http://www.ziprecruiter.com/job/Clinical-Trials-Manager/e25f445c/?source=social-linkedin-group-jobs ******************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=4687419&trk=eml-anet_dig-b_premjb-ttl-cn&ut=1r7w3zeT9YURA1 Financial Analyst (Project) Coherus Biosciences - San Francisco Bay Area Job Description In this critical role reporting to the Vice President of Finance & Administration, your talents will round out our accomplished Coherus Finance team. You will manage projects related to the development of the Company’s manufacturing and operations. Key responsibilities include:

Applies extensive expertise as a project financial analyst within the biopharmaceutical industry to successfully deliver project outcomes while managing stakeholder expectations

Develops and provides plans, timelines, and budgets per project Understands links, conflicts, and financial impacts from project changes and makes

recommendations Explains budget to actual variances for project expenditures Tracks and reviews existing purchase orders for project related activities Attends project-related meetings to ensure appropriate communication of activities Tracks and reports on the progress of projects and expenditures to peers and senior

management Schedules review/approval steps and project updates with senior management Maintains resource plan for each project Anticipates and manages project risks

Desired Skills & Experience BS in a life sciences-related field or finance is required. An advanced degree is

desirable. 5-8 years of finance experience working in the biopharmaceutical industry is required.

Must have a solid understanding of the drug development processes Excellent interpersonal and communication skills, with an ability to balance, negotiate

and work with a variety of internal and external stakeholders to build strategic partnerships

Ability to manage and deliver on multiple competing priorities Demonstrated skills in resource organization, project/task prioritization and schedule

development Excellent quantitative and qualitative analysis skills Must have strong computer skills, including MS Project and Excel, with ability to do

complex models and spreadsheets Working knowledge of project management tools including timeline, communication

plans, risk plans, action item trackers, and project plans Uses MS Project as a tool to create timelines and monitor project progress

Company Description COHERUS BIOSCIENCES We are an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing the entire

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business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Additional Information Posted:January 24, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Pharmaceuticals Job ID:4687419 ********************************************************************* Sr. Systems Engineer for Novel Dialysis Company in the Bay Area This novel dialysis device company in the Bay Area is looking for a Sr. Systems Engineer. This is a newly created position due to exponential expansion in 2013. The company has CE Mark and FDA approval in addition to being financially backed by one of the strongest venture capital firms that has closed on a $40+ million round of funding. With few competitors in the industry, my client is positioning themselves nicely in a lucrative market. • Title: Sr. Systems Engineer • Reports To: Vice President of R&D • Location: Sunnyvale, CA This Systems Engineer will be the hub for the electrical, software and mechanical engineers, and must be someone comfortable working with all those groups while being able to coordinate all the design and manufacturing efforts with writing clear requirements. *************************************** Hiring -- Stats Programmer - San Francisco Apply Here - http://jobvite.com/m?3YodHfw0 Join Onyx Pharmaceuticalshire.jobvite.com We're hiring for Principal Statistical Programmer, Sr. Statistical Programmer, Sr. Manager, Statistical Programming, Principal Biostatistician, Sr.... ***************************************** Go to Thoratec.com to submit your resume. Manufacturing Mechanical Engineer III- Thoratec - Pleasanton Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. The Manufacturing Engineer III, NPI will perform complex activities in providing manufacturing engineering support of existing circulatory support products and the development/transfer into manufacturing of new products. Provides technical solutions to a wide range of difficult problems. Works under only general direction. Independently determines and develops approach to solutions. Requirements Responsibilities: This position is responsible for, but not limited to, the following: Work with cross-functional teams to transfer new products efficiently and effectively into manufacturing. Provide critical assessments of new product/component designs regarding DFM/DFA/DFT

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principles. Work with various internal and external organizations as required developing manufacturing processes or resolving technical issues w/ on-going products. Improve/design existing/new equipment/fixtures/gauging based on product and manufacturing/QA/R&D requirements. Develop and validate manufacturing processes (including identification, design, installation and validation of equipment) for fabrication of products in a clean room environment. Review technical drawings for appropriate dimensions and tolerances for the application. Develop effective fabrication, in-process control, and final quality test procedures. Develop manufacturing process flow diagrams, pFMEAs and process validation procedures. Aid in the selection, evaluation and ramp up of contract manufacturers. Perform process characterization studies. Collect and analyze in process data to evaluate capability and determine areas for process improvement. Drive process improvements and validations through manufacturing implementation. Provide technical support to manufacturing and QA to improve productivity and reduce costs. Provide input and support to Regulatory Affairs for FDA submission and to resolve customer concerns. Participate as a manufacturing lead and/or support a lead on cross-functional core teams. Evaluate process capabilities, cycle times, yield, throughput, labor standards, and environmental impact. Participate in vendor evaluations re: manufacturing capability and capacity, engineering support and overall process quality controls. Minimum Qualifications: Requires a B.S. in Mechanical, Bio, Material or Manufacturing Engineering. Requires five to eight years engineering experience including skills in new product introduction, process development, improvement and validation related to manufacturing electro-mechanical devices. Requires strong analytical, written and verbal communication skills and the ability to interface with all departments. Industry experience with FDA design controls for medical devices (ISO/GMP) required Additional Qualifications: Industry experience with implantable electronics packaging and Li-Ion batteries a plus. Experience with CAD design, SPC, DOE, CMM, six sigma concepts, and/or project management skills a plus. Good organization and time utilization skills. Knowledge of Microsoft programs (Word, Excel, MS Project, Powerpoint). Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer. *************************************** http://www.ariosadx.com/careers/ Sr. Software Engineer, Scientific Data Engineer - Ariosa Diagnostics - San Jose Sr. Software Engineer/Sr. Scientist, Scientific Data Engineer is a full-time position in the Bioinformatics, Data Analysis and Statistics (BDAS) group, to which you would devote all of your professional effort. You would be primarily responsible for management and analysis of data generated by BDAS. Principal responsibilities include: • Design and development of a data management infrastructure to clean, organize, and manage terabytes of research and development data produced by BDAS.

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• Establish data management policies and procedures for long-term data storage and access. • Design and development of software libraries providing efficient and effective access to historical data produced by BDAS. • Integration of internally and externally produced unstructured, semi-structured, and relational data sources. • Collaborate with other teams to identify and support other needs that are addressed by BDAS data stores. Requirements We seek an individual with a successful track record who must be comfortable with a start-up environment. The ideal candidate will have: • Bachelor’s degree in Computer Science, Computer Engineering, Physics or related field with 7-10 years of experience. Master’s or Ph.D. degree preferred. • Extensive experience working with large data stores. Experience with scientific data stores preferred. Experience with genetic and next-generation sequencing data preferred. • Experience developing in C++, C# and/or Java. • Experience using statistical software such as R, S-plus or SAS. Experience developing in R preferred. • Experience developing for a Windows environment preferred. • Strong communicator with ability to maintain open communication with internal employees, managers, and customers as needed. • Ability to work as part of a team. ************************************** Go to Crescendo Bioscience to apply. Automation Engineer I/II - Crescendo Bioscience - SSF As an Automation Engineer you will develop, optimize, implement, and maintain complex automated platforms in support of our Research, Development, and Clinical Laboratory. You will be working cooperatively in a busy laboratory environment, responding to change with flexibility and adapting quickly to evolving circumstances. This is an excellent opportunity for a team player to participate in the growth of a fast-paced, pioneering company that is developing systematic approaches to applying molecular diagnostics to health, disease, and medical practice. Requirements •Develop, optimize, implement, and maintain complex automation platforms for the Clinical,Development, and Research laboratories. •Become an expert in the routine use and maintenance of the Hamilton Robotic System. •Troubleshoot anomalies in any of our routine automated laboratory assays. •Provides training on use, maintenance, and troubleshooting of Hamilton workstations. •Support Clinical Laboratory Scientists with troubleshooting and resolution of laboratory automation issues. •Design and document new test methods to measure equipment performance •Coordinate Hamilton and other equipment installations and qualifications. •Train fellow Engineers to become “experts” in the operation, maintenance, and programming of Hamilton robots. •Develop in-house qualification procedures and associated documents. •Perform Installation Qualification, Operational Qualification, and Performance Qualification procedures on Hamilton robots and associated peripheral instrumentation. •Perform demonstrations for various interestedparties.

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•Maintains technical knowledge by attending vendor trainings. •Complete essential documentation according to company policy. Qualifications: •Familiarity with standard molecular biology techniques strongly preferred (i.e. ELISA) •Familiarity with assay development, optimization and troubleshooting. •Experience with programming and operating liquid handling robots. •Knowledge of HAMILTON Venus scripting languages is desirable. •Be able to work independently to diagnosis and resolve complex hardware and/or software(Venus/LIMS) issues of robotic workstation and other laboratory equipment. •Independently manage projects. •Independently identify and implement engineering and process improvements. •Share information obtained from unique problems or specialized training to Crescendo Team. •Demonstrated mechanical aptitude relevant to automated liquid handlers and other general laboratory equipment. •Experience with using Laboratory Information Management Systems (LIMS) desirable. •Ability to quickly adopt and apply new methods and technologies. •Proficiency in using basic word processing and spreadsheet applications. •Ability to communicate clearly and effectively in writing and verbally. •B.S. degree in molecular biology, genetics, biochemistry, bioengineering or chemical engineering or equivalent experience preferred. •Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed. •Able to integrate and apply feedback in a professional manner. •Able to prioritize and drive to results with a high emphasis on quality. •Ability to work as part of a team . ************************************************************ Apply on company website Sr R&D Engineer, Job ID: 85184- Medtronic - Santa Rosa his position within Endovascular R&D requires technical expertise in the development of innovative products to treat diseases of the vascular system. The Engineer will apply technical principles, theories and concepts while working on complex technical problems. This position will work under general direction and have latitude in determining how to solve problems. The Engineer will participate in R&D development teams on projects from concept through commercialization. Position Responsibilities The successful candidate will support the design, development, and implementation of next generation Endovascular Stent Grafts to address unmet needs. Responsibilities include: • Applying advanced technical principles, theories, and concepts to develop self expanding stent graft implants, delivery system catheters used to deploy them with a high degree of precision and quality, and related devices. • Generating mechanical designs using SolidWorks. • Working with a variety of vendors to rapidly prototype new concepts for mechanical testing and evaluation. • Designing test methods and conducting tests using DOE methodology and other experimental design tools and generating test reports. • Working under consultative direction toward predetermined long range goals and objectives.

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• Maintaining current knowledge of competitive technologies in addition to medical, clinical, technical and biomedical developments in the field • Providing engineering and technical support for products introduced both domestically and internationally. • Conducting and participating in design review meetings. Basic Qualifications BS degree in Mechanical Engineering or equivalent. • Product development and design experience: Minimum 4 years experience with BS degree, minimum 2 years experience with MS degree for Senior Engineer level. Candidates at the Engineer or Principal Engineer level will also be considered. • High level of proficiency in engineering and scientific principles. • Self-starter and driver – able to take on large portions of a project that are not fully defined and execute effectively. • Excellent communication skills both written and verbal. Desired/Preferred Qualifications • Product development and design experience with medical devices. • Proficiency with SolidWorks. • Experience in Six Sigma (DMAIC, DFFS, Green or Black Belt), tolerance analysis, GD&T, and statistics. • A working knowledge of manufacturing, quality control, preclinical and clinical development and regulatory issues pertaining to Endovascular products. • A proven track record of working effectively in a matrix organization within a highly cross-functional and collaborative environment. *************************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally.

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See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills

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Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should

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include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved.

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___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************* Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com

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There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas

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and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************