Careers in Medical and Scientific Writing

Laura McCormick, PhDVice President Associate Practice Leader

Tamara Fink, PhDAssociate Scientific Director

ProEd Communications, IncBeachwood, Ohio

Agenda

Introduction to ProEdIntroduction to medical and scientific writing

Career optionsWork product examples

Qualifications, experience, and trainingResources

Founded in 1991Fully integrated health science communications companyHeadquartered in Beachwood, Ohio~80 employees with diverse perspectivesDomestic and global execution

ProEd: Who We Are

Omnicom GroupDiversified Agency Services (DAS)> 160+ marketing services and specialtycommunication companies�• A&P�• PR�• Branding�• DTC/DTP�•Medical education

The Healthcare Consultancy Group

Why Consider A Career In Medical Writing?

Work is engagingDiverse exposure to therapeutic areasCutting edge drug development

Lucrative and in high demandSee the world

Prague, Czech Republic

Career Options

Scientific communications / medical educationPharmaceutical industryGeneral science or medical publications industry AdvertisingFreelance writing

Employers

10%

34%

3%8%12%

7%

5%

7%

14%Univ or med school

Pharmaceutical company

Association or professional societyJournal or publisher

Communication / advertising agency

Healthcare organization

Research orEducation

Contract researchorganization

Other

Medical Writing Opportunities Within the Pharmaceutical Industry

Scientific communications Manage publications plansDevelop manuscripts, abstracts, postersMedical education

Medical promotionRegulatory

Develop clinical study reports (CSR)Write new drug application (NDA) documentsSupport preparations for FDA meetings such as advisory committee meetings (ACM)

Portugal

Lisbon Porto

What is medical writing all about?

Publications

ManuscriptsCongress activities

AbstractsPostersOral presentationsBooth materials

Supportive Publications Services

Strategic literature analysesCongress intelligenceAd hoc scientific analysesInteractive CD-ROM bibliographySupplementsWhite papers

Booth Collaterals

Illustration

Medical Education

Corporate-sponsored symposia at medical congressesSpeaker trainingSpeaker bureauSlide librariesWebsite content

Key opinion leader portalsMonographs

Education Materials

Slide Libraries

Web Portals

Pharmaceutical Company Training and Information Services

Sales representative training manualsMedical science liasion (MSL) materials

TrainingPhysician educationQuestion and answer documents

Reference libraries

Training Materials

Oncology Learning System

Regulatory

Clinical trial protocolsInvestigators brochure and updatesRegulatory documents

Clinical Study Reports (Phase I-IV) Integrate safety summaries

Patient narrativesPolicy documentsSubmissions (investigational new drug application)IND and NDA annual reports, amendments, supplementsAdvisory committee preparation

FDA advisor briefing book

Promotion

NewslettersPatient education materialsPublic relations materialsAdvertising copy for pharmaceuticals and other productsInternet contentCDsMagazine articles - popular pressDetail aidsLaunch materials

Who Does What In The Agency World?

AdvertisingTradepress

Promotion Legal / Regulatory

AdvertisingAgency

Full Service Medical Communications

Clinical ResearchOrganization

PublicationsCongressmaterialsAdvisoryboards

Clinical study reportsINDNDABLA

Sales aidsTraining materialsBoothmaterialsDrug development strategy

RegulatoryconsultingHealth economics researchand pubs

Medical Writing Services: ProEd

Advisory boardsScientific content developmentScientific animationsInteractive education solutionsMeeting & conference programmingCompetitive intelligenceDisease backgroundersScientific research support

ScientificCommunications

Strategy workshopsMarket shaping & preparation strategyHCP promotional educationSales force educationBranding through visual nomenclature & animation Patient education & community marketing

Medical Strategy and Promotion

Health authority Meetings

FDA advisory committee meetingsEMEA

Submission managementRisk managementLabeling negotiation strategy

RegulatoryCommunications

Medical expert relationships High science

Select Client List

Barcelona, SpainSacrada de familia

GaudiPark Güell

How do I get there from here?

Qualifications

Attention to detail - thorough and accurateGood communication skills (written and verbal)Ability to write well and tailor information to specific audiences

Clear, conciseLogical story flow

Ability to work with team members of diverse educational backgroundsAbility to work independently (often remotely)Deadline orientedGood organization and management skills

Education and Training

Education level parallels job requirementsBS or MSPhD

Often requires 1-2 years postdoctoral trainingPharmDMD

Excellent software skillsMay require testing or additional training

Training and More Information

Read medical and pharmaceutical journalsSubscribe to online newsletters (e.g. National Center for Education in Maternal and Child Health)Study basic statisticsObtain and be familiar with style guides and medical dictionaries (eg AMA)Familiarize yourself with FDA guidelinesGain software skills (MS Word, PowerPoint, Excel)

Training and More Information

Complete a course in pharmacology Enroll in AMWA’s continuing education certification programMedical writing program through college or universityPharmaceutical Education & Resources InstitutePharmaceutical industry training courses

Focus on drug development and marketing

Choosing Between Freelance Writing and Industry (Pharma or Agency)

Decision rests onExperienceFinancial and lifestyle needsTolerance for riskPreference for team environment vs soloPersonal motivation and disciplineIndustry trends and job market

Additional Resources

Bonk RJ. Medical Writing for Pharmaceutical Research. In: Medical Writing in Drug Development. A Practical Guide for Pharmaceutical Research. New York, NY: The Pharmaceuticals Product Press; 1998:3-36.American Medical Writer’s Association http://www.amwa.org

Links training, ethical publications guidance, medical writing resources...

Additional Resources

Drug Information Association http://www.diahome.org/DIAHome Pharmaceutical Education & Resources Institutehttp://www.peri.org/become_faculty.cfmNational Association of Science Writershttp://www.nasw.orgPharmaceutical regulatory affairs traininghttp://www.iir-events.com/IIR-conf/PTI/EventView.aspx?EventID=1621

Additional Resources

Center for Professional Innovation and Education (Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries )http://www.cfpie.comA Marketing Primer for Freelance Medical Writers, Lori De Milto, AMWA Journal, Vol. 14, No. 2, Spring 1999. AMA Manual of Style: A Guide for Authors and Editors. JAMA & Archives Journals, Mar 15, 2007.

Contact information:Terri Bednar, HR GeneralistPhone: 216 378-8854Phone: 216 595-7919e-mail: terri.bednar@proedcom.com