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

1. SDBN August 26th 2013 Event:
The How, What, and Why of
“Alternative” Careers
San Diego, California
Click For Summary

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. 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. 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. Establish Career Goals
IDEAL CAREER
Good news: Being a good writer will help whatever you do

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. 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. 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. 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. 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. Outline
 What is a Regulatory Affairs Professional
 Why I entered this field
 How did I do it

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. 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. RA Professional - III
© 2007 Regulatory Affairs Professionals Society

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. 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. 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. 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. 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. THANK YOU!

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. 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