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

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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