This document discusses opportunities for medical writing jobs in three main areas: medical writing, IT organizations, and regulatory publishing. It provides details on the types of organizations that employ medical writers, including those that produce healthcare products and must comply with regulations. The document outlines the skills and qualifications needed for medical writing jobs, such as experience with statistics, epidemiology, and biomedical literature. It also describes the major parts and contents of regulatory submissions that medical writers assist with, such as New Drug Applications, clinical study reports, and electronic common technical documents. The document provides advice on transitioning into medical writing and finding job opportunities through networking and leveraging current skills.

1. Medical writing andhigh tech writersSTC NNEApril 14, 2010

2. WhereAre theMedical WritingJobs?Within one of three groups Medical WritingIT OrganizationRegulatory Publishingof organizations that produce health care products

3. WhoAre TheseOrgs thatDoMedical Writing?Organizations that must comply with Federal and national laws surrounding the delivery of health care products

4. WhichOrgsMustComply?Producers of products that eitherTouch orGo into a human bodyPart A

5. WhichOrgsMustComply?Handlers of informationPersonally Identifiable Information (PII) inDatabasesSoftware toolsPart B

6. Who Makes a Perfect Medical Writer?In their minds, aPhi Beta Kappa from an IvyMajor in Microbiology, Organic Chemistry, and NeurosciencePh.D. from Ivy or Public IvyM.D. that chose writing

7. WhatDoYou Need For Medical Writing?Curiosity and Regular Involvement withStatisticsEpidemiologyBiomedical Literature

8. What IsStatistics?Science of making effective use of numerical data relating to groups of individuals or experiments

9. What IsEpidemiology?Study of factors affecting the health and illness of populations in evidence-based medicine and involves study, design, collection, and analysis of health data

10. What IsBiomedicalLiterature?Also labeled Experimental Medicine or Medical Research, the discipline isbasic, applied, or translational research conducted to aid and support the body of knowledge of medicine

11. What Will You Write?Submissions (FDA)Submissions (EMA)Submissions (Health Canada)Submissions (Japan Health)Submissions (Every EU member)Submissions

12. What Is a Submission?When paper was OK, a submission wasAn 18-wheeler filled with paper80,000 sheets of paper averageDelivered to a health care regulatory agency (such as the FDA)Now a submission is all of the above in the eCTD (electronic) format

13. General ConsiderationsRequesting a Pre-Assigned Application Number Abbreviated New Drug Applications (ANDAs)Annual Reports for New Drug Applications (NDAs)Carcinogenicity DataDigital Electrocardiogram (ECG) Data Drug Master FileWhatAre theParts of aSubmission?

14. Investigational New Drug Applications (INDs)Launch Material and Other Submissions to the Division of Drug Marketing, Advertising, and Communications (DDMAC)New Drug Applications (NDAs)Post-marketing Adverse Events ReportingStructured Product Labeling (SPL)Information Packages for MeetingsWhatAre theParts of aSubmission?

15. Who Will Approve Everything That You Write?FDAEMAHealth CanadaJapan HealthAll will approve everything, every word, every phrase, every sentence and approve with an unrelenting and unforgiving eye

16. What WillYou Do InIT?Write documentation that supports IT quality management systems as outlined in21 CFR Part 11Computer Systems Validation (CSV)

17. WhatWillYouWrite?CSV KitsValidation PlanRequirements SpecificationsDesign DocumentsTest PlansTest ScriptsImplementation PlansTest Summary ReportValidation Summary Report

18. WhatWillYou Do inRegulatoryPublishing?Build the modules in the electronic common technical document (eCTD) submissionModule 1 Administrative InformationModule 2 SummariesModule 3 QualityModule 4 Nonclinical Study ReportsModule 5 Clinical Study Reports

19. WhatWillYouPublish?Publish Modules 1 – 5 with software tools such asROSETTA regulatory software PharmaReady™ eCTD Office LiquentInSightMasterControl/DatafarmGxP2eCTD Connector

20. What Can You Do toTransition?PrepareDecide whether the three interests are youRefresh your science backgroundKnow your skillsUse skill building exercise of What Color Is Your Parachute?Match your skills to their needs

21. How Do You Find A Match?Identify organizations that use your skillsNetwork with people in target organizations to uncover workUse LinkedIn (and the other social networks) to find people in target organizationsCount on the fact that people will help you

22. How Can You Leverage?On the contract / jobLearn the organization and its many groupsBe prepared with a 30-second elevator speechIntroduce yourself at the coffee area, in the elevatorSeek out and introduce yourself to employees who might use your servicesMake an effort to meet groups that could use your services

23. Another ViewpointReadLinkedInSociety for Technical Communication Discussion Group“To what extent are scientific, medical, and pharmaceutical writing part of technical communication or are they in a class by themselves?”Mark Yellin’s Response

24. Thank YouBill Gruenerbill@billgruener.com