Getting Started in Medical Writing Workshop at the AMWA-DVC 2005 Getting Started in Medical Writing Workshop ... Report (CTR) Protocol Some ... Informal Medical Writing Training

Presented at thePresented at the AMWAAMWA--DVC DVC 2005 Getting Started in Medical Writing Workshop2005 Getting Started in Medical Writing Workshop

Scope of Medical WritingScope of Medical Writing

Getting Started in Medical Writing Workshop Getting Started in Medical Writing Workshop January 15, 2005, Debbie Early, PhD

©© Copyright 2005 Debbie Early, PhD

Overview of Scope of Medical Overview of Scope of Medical WritingWriting

IntroductionsIntroductions

Characteristics of Successful Medical WritersCharacteristics of Successful Medical Writers

Medical Writing Jobs, Assignments and EmployersMedical Writing Jobs, Assignments and Employers

Career Paths to Scientific and Marketing Medical WritingCareer Paths to Scientific and Marketing Medical Writing

Salaries of Medical WritersSalaries of Medical Writers

IntroductionsIntroductions

What do you know about Medical What do you know about Medical Writing as a Career?Writing as a Career?

Work is interesting and lucrative, high demand existsWork is interesting and lucrative, high demand exists

Source: Sahadi, 2004Source: Sahadi, 2004

Two types of medical writer:Two types of medical writer:

Scientific (medicine, science, pharmacy degree etc.)Scientific (medicine, science, pharmacy degree etc.)

Marketing (journalism, English degree)Marketing (journalism, English degree)

Source: Bonk, 1998Source: Bonk, 1998

Medical Writers’ Satisfaction With Medical Writers’ Satisfaction With WorkWork

Very Satisfied

Mostly Satisfied

Satisfied

Mostly Unsatisfied Very Unsatisfied

30%

1%5%

19%

45%

Source: Gray and Hamilton, Source: Gray and Hamilton, 20042004

Characteristics of Medical WritersCharacteristics of Medical Writers

Who becomes a Medical Writer?Who becomes a Medical Writer?

Requires a combination of technical skills in Requires a combination of technical skills in medical sciences and rhetorical skills in language medical sciences and rhetorical skills in language artsarts

2004 AMWA survey showed approximately:2004 AMWA survey showed approximately:65% AMWA members are educated at 65% AMWA members are educated at masters or doctorate levelmasters or doctorate level50% are science educated; the other half are 50% are science educated; the other half are humanities educatedhumanities educated

Highest Educational LevelHighest Educational Level

Advanced Degree

Bachelor’s Degree

Master’s Degree

Associate’s Degree or Below

2%

33%

35%

30%

Source: Gray and Source: Gray and Hamilton, 2004Hamilton, 2004

Field of Highest DegreeField of Highest DegreeCommunication Communication

(4.3%)(4.3%)

Public Health (3.1%)Public Health (3.1%)

Nursing (2.4%)Nursing (2.4%)

Technical Writing Technical Writing (2.4%)(2.4%)

Other (24.3%)Other (24.3%)

Science (33.8%)Science (33.8%)

English (14.4%)English (14.4%)

Journalism Journalism (5.3%)(5.3%)

Pharmacy (5.1%)Pharmacy (5.1%)

Medicine (4.8%)Medicine (4.8%)

Source: Gray and Hamilton, Source: Gray and Hamilton, 20042004

Some Shared Attributes and Some Shared Attributes and CharacteristicsCharacteristics

Attention to detailAttention to detailAbility to writeAbility to writeAbility to work across teams (often remotely)Ability to work across teams (often remotely)Ability to work independentlyAbility to work independentlyGood communicatorsGood communicatorsKnowledge or aptitude for understanding Knowledge or aptitude for understanding medicinemedicineEducation: College education in science, Education: College education in science, medicine, English or journalismmedicine, English or journalism

More Shared Attributes and More Shared Attributes and CharacteristicsCharacteristics

Deadline orientatedDeadline orientated

Thorough researchThorough research

AccuracyAccuracy

Logical OrganizationLogical Organization

Clear thinking and writingClear thinking and writing

Ability to write clearlyAbility to write clearly

Source: AMWASource: AMWA--DVC Web site, 2004DVC Web site, 2004

Medical Writing Jobs and Medical Writing Jobs and EmployersEmployers

Examples of Work Scientific Medical Examples of Work Scientific Medical Writers Undertake Writers Undertake

Journal abstracts and articles Journal abstracts and articles Advertising copy for pharmaceuticals Advertising copy for pharmaceuticals and other products and other products Internet content Internet content Medical education materials Medical education materials Pharmaceutical marketing and Pharmaceutical marketing and advertisingadvertising

More Examples of Work Scientific More Examples of Work Scientific Medical Writers UndertakeMedical Writers Undertake

Physician speechesPhysician speechesPosters Posters Sales training manuals Sales training manuals Regulatory documents (clinical trial Regulatory documents (clinical trial reports, integrated summaries of efficacy reports, integrated summaries of efficacy and safety, investigator brochures etc.) and safety, investigator brochures etc.) Policy documentsPolicy documents


Food and Drug Administration (FDA) Regulations Food and Drug Administration (FDA) Regulations International Conference on Harmonization and Good International Conference on Harmonization and Good Clinical Practice Guidelines (ICHClinical Practice Guidelines (ICH--GCP) GCP) New Drug Application (NDA)New Drug Application (NDA)Investigational New Drug Application (IND Application)Investigational New Drug Application (IND Application)Informed Consent Form (ICF); also know as Informed Informed Consent Form (ICF); also know as Informed Consent Document (ICD)Consent Document (ICD)Clinical Study Report (CSR); also known as Clinical Trial Clinical Study Report (CSR); also known as Clinical Trial Report (CTR)Report (CTR)ProtocolProtocol

Some Scientific Medical Some Scientific Medical Writing Terms Writing Terms

Submissions (Investigational New Drug Submissions (Investigational New Drug Application) Application) IND and NDA Annual Reports, Amendments, IND and NDA Annual Reports, Amendments, Supplements Supplements Clinical Study Reports (Phase IClinical Study Reports (Phase I--IV) IV) Subject NarrativesSubject NarrativesInvestigators Brochure and Updates Investigators Brochure and Updates ProtocolsProtocols

Examples of Examples of Regulatory DocumentsRegulatory Documentsin the Pharmaceutical Industryin the Pharmaceutical Industry

Examples of Work Marketing Examples of Work Marketing Medical Writers UndertakeMedical Writers Undertake

Advertising copy Advertising copy Articles Articles CDs CDs Editing Editing Internet content Internet content Magazine articles Magazine articles -- popular presspopular pressMagazine articles Magazine articles -- professional pressprofessional pressMarketing materialsMarketing materials

More Examples of Work Marketing More Examples of Work Marketing Medical Writers UndertakeMedical Writers Undertake

Newsletters Newsletters Patient education materials Patient education materials Public relations materials Public relations materials Proofreading Proofreading Training manualsTraining manuals


Primary EmployerPrimary Employer

5

3%

7%

12%8%

34%

10%14%

7%CRO

Other

Research or Education

Health

Care OrgCommunication or Advertising Co

Journal or Publisher

Association or

Professional Society

Pharmaceutical

Company

University or Medical School

Source: Gray Source: Gray and Hamilton, 2004and Hamilton, 2004

Sample JobsSample JobsMedical writer for medical communications firm: to Medical writer for medical communications firm: to create pharmaceutical/health care educational programscreate pharmaceutical/health care educational programs

Scientific medical writer for medical communications Scientific medical writer for medical communications company: to prepare clinical and precompany: to prepare clinical and pre--clinical clinical manuscripts, abstracts, and posters; clinical trial reports; manuscripts, abstracts, and posters; clinical trial reports; and medical education materials and medical education materials

Director of scientific editing for a biotech company: to Director of scientific editing for a biotech company: to edit and/or reedit and/or re--write scientific papers and grant write scientific papers and grant applications, and educate and train staff in scientific applications, and educate and train staff in scientific writing and editing writing and editing


Career Paths to Scientific and Career Paths to Scientific and Marketing Medical WritingMarketing Medical Writing

Career Paths to Medical WritingCareer Paths to Medical Writing

There are two main career paths to becoming a There are two main career paths to becoming a medical writer:medical writer:

Writers who learn to write about medicineWriters who learn to write about medicineScientists who learn to writeScientists who learn to write

Newer path is to study to become a medical writer (e.g. Newer path is to study to become a medical writer (e.g. University of the Sciences in Philadelphia Masters in University of the Sciences in Philadelphia Masters in Biomedical Communications)Biomedical Communications)

More about Career Paths to Medical More about Career Paths to Medical WritingWriting

Best way to learn:Best way to learn:build skills build skills make contacts/network make contacts/network explore career opportunities (e.g., by joining explore career opportunities (e.g., by joining AMWA)AMWA)

Also pursue informal/formal trainingAlso pursue informal/formal training

Informal Medical Writing TrainingInformal Medical Writing TrainingRead medical and pharmaceutical journalsRead medical and pharmaceutical journalsSubscribe to online newsletters (e.g. National Center for Subscribe to online newsletters (e.g. National Center for Education in Maternal and Child Health)Education in Maternal and Child Health)Develop an understanding of basic statisticsDevelop an understanding of basic statistics

Obtain and be familiar with style guides and medical Obtain and be familiar with style guides and medical dictionaries (e.g. AMA)dictionaries (e.g. AMA)Keep up to date withKeep up to date with

FDA guidelinesFDA guidelinesSoftware skills (MS Word, PowerPoint, Acrobat)Software skills (MS Word, PowerPoint, Acrobat)


Formal Medical Writing TrainingFormal Medical Writing Training

Complete a course in statistics, Complete a course in statistics, pharmacology or life sciencespharmacology or life sciencesEnroll in AMWA’s continuing education Enroll in AMWA’s continuing education certification programcertification programUndertake a medical writing program Undertake a medical writing program through college or universitythrough college or university


Freelance or EmployeeFreelance or Employee

Decision rests on:Decision rests on:ExperienceExperienceFinancial and lifestyle needsFinancial and lifestyle needsTolerance for riskTolerance for riskNeed to be with other peopleNeed to be with other peopleAbility to market oneselfAbility to market oneselfPersonal motivation and disciplinePersonal motivation and disciplineIndustry trends and job marketIndustry trends and job market

Salaries of Medical Writers: Salaries of Medical Writers: Employee and FreelanceEmployee and Freelance

Medical Writers may Earn…Medical Writers may Earn…

Between about $30,000 to $100,000Between about $30,000 to $100,000

Source: Gray and Hamilton, 2004Source: Gray and Hamilton, 2004

Results of Regression AnalysisResults of Regression Analysisin 1058 subjectsin 1058 subjects

High correlation between age and years experience, High correlation between age and years experience, (years experience used for analysis)(years experience used for analysis)

AMWA certification not significant in modelAMWA certification not significant in model

Men earn more than women, even when they have Men earn more than women, even when they have similar experience and educationsimilar experience and education

RR22 = 0.5123 (model explains 51% of variance in = 0.5123 (model explains 51% of variance in income)income)

Source: Gray and Hamilton, 2004Source: Gray and Hamilton, 2004

More Regression Analysis More Regression Analysis

+ + $16,904$16,904

Master’s DegreeMaster’s Degree

+ + $25,356 $25,356

Advanced DegreeAdvanced Degree

+ + $7,969 for being male$7,969 for being male

++$8,452$8,452

Bachelor’s DegreeBachelor’s Degree

++$1,263 each year of experience$1,263 each year of experience

++$23,562 for being employed by pharmaceutical or$23,562 for being employed by pharmaceutical or

communications or advertising firmcommunications or advertising firm

Associate’s degree or less = $19,768 Associate’s degree or less = $19,768

Source: Gray Source: Gray and Hamilton, 2004and Hamilton, 2004

To recap…..To recap…..

Characteristics of Successful Medical WritersCharacteristics of Successful Medical Writers

Medical Writing Jobs and EmployersMedical Writing Jobs and Employers

Career Paths to Scientific and Marketing Medical WritingCareer Paths to Scientific and Marketing Medical Writing

Salaries of Medical WritersSalaries of Medical Writers

Suggested Additional ReadingSuggested Additional Reading

Iverson C. Style. In: Iverson C. Style. In: American Medical Association American Medical Association Manual of Style.Manual of Style. A Guide for Authors and EditorsA Guide for Authors and Editors. 9th ed. . 9th ed. Media, Pa: Lippincott Williams & Williams; 1998.Media, Pa: Lippincott Williams & Williams; 1998.

Schwager E. Grammar and Usage. In: Schwager E. Grammar and Usage. In: Medical English Medical English Usage and AbusageUsage and Abusage. Phoenix, AZ: Oryx Press; 1991.. Phoenix, AZ: Oryx Press; 1991.

ReferencesReferences

Bonk RJ. Medical Writing for Pharmaceutical Research. In: Bonk RJ. Medical Writing for Pharmaceutical Research. In: Medical Medical Writing in Drug Development. A Practical Guide for PharmaceuticaWriting in Drug Development. A Practical Guide for Pharmaceutical l Research.Research. New York, NY: The Pharmaceuticals Product Press; New York, NY: The Pharmaceuticals Product Press; 1998:31998:3--36.36.

Gray T and Hamilton CW. Findings From the 2004 AMWA Salary Gray T and Hamilton CW. Findings From the 2004 AMWA Salary Survey. Survey. American Medical Writers Association JournalAmerican Medical Writers Association Journal. . 2004;19(4):1452004;19(4):145--151. 151.

Sahadi J. Interesting sixSahadi J. Interesting six--figure jobs. A look at lucrative careers that figure jobs. A look at lucrative careers that let you roll the dice, defend against terror and write about drulet you roll the dice, defend against terror and write about drugs. gs. CNN/Money 2004. Available at: CNN/Money 2004. Available at: http://money.cnn.com/2004/09/08/pf/sixfigs_seven/http://money.cnn.com/2004/09/08/pf/sixfigs_seven/. Accessed . Accessed December 21, 2004.December 21, 2004.

EvaluationEvaluation