SDBN August 26th 2013 Event:
The How, What, and Why of
“Alternative” Careers
San Diego, California
Click For Summary
0 10 20 30 40 50 60
Regulatory
Science Writing
Science Policy
Legal/IP
Project Management
Consulting
Marketing
Medical Com...
Raymond Clark, Ph.D., Project Manager for Global
Health, San Diego State University and
Founder, National Postdoctoral Ass...
Ray’s Path to Science Writing
Title Place Location
PhD Pharmacology Vanderbilt Nashville
Scientist Astellas Osaka/Tokyo
Ma...
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-Writing
Ma...
Cultivate Your Network
• Not just ‘Ask for favors when you need them’
• Keep in touch
– Set up archiving/management system...
How to Get Started
• Build your writing resume
– Volunteer to write – write as much as you can!
• Seek out freelance oppor...
Raymond Clark, Ph.D., Project Manager for Global
Health, San Diego State University and Founder,
National Postdoctoral Ass...
Jennifer Grodberg, PhD, RAC (US)
Senior Director, Regulatory Affairs, Trius Therapeutics, Inc.
President, American Medical...
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 operatio...
RA Professional - II
 Monitor the continuous evolution in science and changes in the
regulatory environment, healthcare s...
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 diagnosti...
RA Professional - V
 Knowledge base of the profession blends content from the
sciences, law and business
 Individuals en...
RA Professional - VI
 Additional skill sets
 Facilitation – reaching consensus across functional areas
 Project managem...
Why I entered this field
 10.5 years in early stage drug discovery – time for
something different
 Interest in later sta...
How I entered this field
Challenge: Most individuals entering the regulatory
profession have prior professional experience...
THANK YOU!
Raymond Clark, Ph.D., Project Manager for Global
Health, San Diego State University and Founder,
National Postdoctoral Ass...
AAAS: http://www.aaas.org/programs/science_policy/
ACS Policy Fellowships:
http://www.acs.org/content/acs/en/policy/policy...
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Life Science Alternative Careers Workshop

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San Diego Biotechnology Network's alternative careers event August 26 2013.

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Life Science Alternative Careers Workshop

  1. 1. SDBN August 26th 2013 Event: The How, What, and Why of “Alternative” Careers San Diego, California Click For Summary
  2. 2. 0 10 20 30 40 50 60 Regulatory Science Writing Science Policy Legal/IP Project Management Consulting Marketing Medical Communications/Liaison Product Management/Development Business Development QA/QC Technical Writing/Support Poll Results: What “Alternative” Careers Are You Interested In?
  3. 3. 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)
  4. 4. Ray’s Path to Science Writing Title 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
  5. 5. Establish Career Goals IDEAL CAREER Good news: Being a good writer will help whatever you do
  6. 6. Making yourself marketable as a freelancer Your writing business Business/ Financial Analysis Programming Grant-Writing Marketing Copy Graphic Design Sub- contractor Primary $$ Indirect Work Rely on self $ Direct Work Rely on Contractor
  7. 7. 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
  8. 8. 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
  9. 9. 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)
  10. 10. 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
  11. 11. Outline  What is a Regulatory Affairs Professional  Why I entered this field  How did I do it
  12. 12. 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
  13. 13. 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
  14. 14. RA Professional - III © 2007 Regulatory Affairs Professionals Society
  15. 15. 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
  16. 16. 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
  17. 17. 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
  18. 18. 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!
  19. 19. 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
  20. 20. THANK YOU!
  21. 21. 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)
  22. 22. AAAS: http://www.aaas.org/programs/science_policy/ ACS Policy Fellowships: http://www.acs.org/content/acs/en/policy/policyfellowships.html American Society for Microbiology http://www.asm.org/index.php/public-policy/public-and-scientific-affairs- board/congressional-science-fellowship National Academies http://sites.nationalacademies.org/pga/policyfellows/ CCST Fellowship Program http://fellows.ccst.us/index.php
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