life science alternative careers workshop
DESCRIPTION
San Diego Biotechnology Network's alternative careers event August 26 2013.TRANSCRIPT
SDBN August 26th 2013 Event: The How, What, and Why of
“Alternative” Careers
San Diego, CaliforniaClick For Summary
Regulatory
Science Writing
Science Policy
Legal/IP
Project Management
Consulting
Marketing
Medical Communications/Liaison
Product Management/Development
Business Development
QA/QC
Technical Writing/Support
0 10 20 30 40 50 60
Poll Results: What “Alternative” Careers Are You Interested In?
Raymond Clark, Ph.D., Project Manager for Global Health, San Diego State University and Founder, National Postdoctoral Association
Jennifer Grodberg, Ph.D., R.A.C, Senior Director, Regulatory Affairs-Trius Therapeutics, Inc. and President, American Medical Writers Association Pacific-SW Chapter
Raymond Price, Ph.D., MBA, Director of Business Development at Bioseek, Founder, The Prices Write
Lisa Silverman, Ph.D., JD, Associate at Morrison & Foerster LLP
Hugo Villar, Ph.D., MBA, Director of Science & Technology, UC San Diego Extension (Moderator)
Ray’s Path to Science WritingTitle Place Location
PhD Pharmacology Vanderbilt Nashville
Scientist Astellas Osaka/Tokyo
Manager of Business Development
Acucela/ Biocortech
Seattle/Paris
Executive MBA INSEAD Paris/Singapore/ Abu Dhabi
Director of Business Development
BioSeek San Diego
Founder and Sole Proprietor The Prices Write
Global
• Local ‘language’ expert to build portfolio– Edited >200 papers, abstracts, posters, even annual report!
• Freelance company (Japan) with expert reviews• Build portfolio as subcontractor
Establish Career Goals
IDEAL CAREER
Good news: Being a good writer will help whatever you do
Making yourself marketable as a freelancer
Your writing
business
Business/ Financial Analysis
Programming
Grant-WritingMarketing Copy
Graphic Design
Sub-contractor Primary
$$
Indirect Work
Rely on self
$
Direct Work
Rely on Contractor
Cultivate Your Network• Not just ‘Ask for favors when you need them’• Keep in touch
– Set up archiving/management system (Outlook, etc.)– Alerts for new papers for authors you know well
• Utilize LinkedIn and other online and in person networking tools.
• Be active in local and national chapters of the organizations where you are a member.– Volunteer at a conference (e.g., at registration) for reduced
registration and excellent networking opportunity
• Share information– Scarcity vs abundance mentality
How to Get Started
• Build your writing resume– Volunteer to write – write as much as you can!
• Seek out freelance opportunities – Company, University, Tech Transfer
• Specialize• Online presence: LinkedIn, Twitter, FB• Opportunities: SDBN, ScienceOnline, OBR
Raymond Clark, Ph.D., Project Manager for Global Health, San Diego State University and Founder, National Postdoctoral Association
Jennifer Grodberg, Ph.D., R.A.C, Senior Director, Regulatory Affairs-Trius Therapeutics, Inc. and President, American Medical Writers Association Pacific-SW Chapter
Raymond Price, Ph.D., MBA, Director of Business Development at Bioseek, Founder, The Prices Write
Lisa Silverman, Ph.D., JD, Associate at Morrison & Foerster LLP
Hugo Villar, Ph.D., MBA, Director of Science & Technology, UC San Diego Extension (Moderator)
The How, What, and Why of Alternative Careers:
A Career in Regulatory Affairs
Jennifer Grodberg, PhD, RAC (US)Senior Director, Regulatory Affairs, Trius Therapeutics, Inc.
President, American Medical Writers Association Pacific Southwest Chapter
Fellow, American Medical Writers Association
San Diego Biotechnology Forum: August 26, 2013
Outline
What is a Regulatory Affairs Professional
Why I entered this field
How did I do it
What is a Regulatory Affairs Professional Regulatory affairs (RA) professionals provide strategic,
tactical and operational direction and support for working within the regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world
Play a role throughout the healthcare product life cycle, from concept (i.e., drug discovery) through production obsolescence
© 2007 Regulatory Affairs Professionals Society
RA Professional - II
Monitor the continuous evolution in science and changes in the
regulatory environment, healthcare sector and general economics
Most are involved to some degree in bridging the gap between regulatory-related functions and organization and business activities
Employment settings
Pharmaceutical industry sector
Government
academic institutions
clinical research organizations and other research organizations© 2007 Regulatory Affairs Professionals Society
RA Professional - III
© 2007 Regulatory Affairs Professionals Society
RA Professional - IV Provide support for a wide range of product types,
including Medical devices In vitro diagnostics Biologics and biotechnology Nutritional products Cosmetics Veterinary products
RA Professional - V Knowledge base of the profession blends content from the
sciences, law and business Individuals entering the regulatory profession generally
have previous experience in Scientific and clinical research Clinical laboratory work Clinical professions such as medicine or pharmacy Quality Manufacturing
Majority have post baccalaureate education and/or graduate degrees
© 2007 Regulatory Affairs Professionals Society
RA Professional - VI Additional skill sets
Facilitation – reaching consensus across functional areas Project management – many regulatory submissions require
adherence to structured timelines Writing
Coordinating document preparation Content generation & editing Types of documents:
Meeting requests/meeting background materials Investigational new drug applications Pediatric plans, Requests for FDA comment/waivers, special
product designations (eg., fast track, qualified infectious disease product designation, etc), package inserts, etc
Why I entered this field 10.5 years in early stage drug discovery – time for
something different
Interest in later stages of the drug development process
3rd layoff!
How I entered this field Challenge: Most individuals entering the regulatory
profession have prior professional experience
Took regulatory writing courses (through AMWA) and obtained certificate in regulatory affairs (UCSD Extension)
Reorganized resume – coursework and transferable skills listed prior to work experience (project leadership/timeline management/writing/technical) emphasized deliverables
Sought ground level job to obtain experience pay your dues!® Be willing to take a job that could ultimately lead to the actual job of
interest Networked networked networked
THANK YOU!
Raymond Clark, Ph.D., Project Manager for Global Health, San Diego State University and Founder, National Postdoctoral Association
Jennifer Grodberg, Ph.D., R.A.C, Senior Director, Regulatory Affairs-Trius Therapeutics, Inc. and President, American Medical Writers Association Pacific-SW Chapter
Raymond Price, Ph.D., MBA, Director of Business Development at Bioseek, Founder, The Prices Write
Lisa Silverman, Ph.D., JD, Associate at Morrison & Foerster LLP
Hugo Villar, Ph.D., MBA, Director of Science & Technology, UC San Diego Extension (Moderator)
AAAS: http://www.aaas.org/programs/science_policy/
ACS Policy Fellowships:http://www.acs.org/content/acs/en/policy/policyfellowships.html
American Society for Microbiologyhttp://www.asm.org/index.php/public-policy/public-and-scientific-affairs-board/congressional-science-fellowship
National Academieshttp://sites.nationalacademies.org/pga/policyfellows/
CCST Fellowship Programhttp://fellows.ccst.us/index.php