At the April 2010 meeting of the Society for Technical Communication Northern New England Chapter, medical writer Bill Greuner described his transition from technical writer to medical writer, discussing what technical writers looking into this field should look for and how to prepare.

1. Medical writing andhigh tech writers STC NNE April 14, 2010

2. WhereAre theMedical WritingJobs? Within one of three groups Medical Writing IT Organization Regulatory Publishing of 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 either Touch or Go into a human body Part A

5. WhichOrgsMustComply? Handlers of information Personally Identifiable Information (PII) in Databases Software tools Part B

6. Who Makes a Perfect Medical Writer? In their minds, a Phi Beta Kappa from an Ivy Major in Microbiology, Organic Chemistry, and Neuroscience Ph.D. from Ivy or Public Ivy M.D. that chose writing

7. WhatDoYou Need For Medical Writing? Curiosity and Regular Involvement with Statistics Epidemiology Biomedical 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 is basic, 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 was An 18-wheeler filled with paper 80,000 sheets of paper average Delivered 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 Considerations Requesting a Pre-Assigned Application Number Abbreviated New Drug Applications (ANDAs) Annual Reports for New Drug Applications (NDAs) Carcinogenicity Data Digital Electrocardiogram (ECG) Data Drug Master File WhatAre 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 Reporting Structured Product Labeling (SPL) Information Packages for Meetings WhatAre the Parts of aSubmission?

15. Who Will Approve Everything That You Write? FDA EMA Health Canada Japan Health All 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 in 21 CFR Part 11 Computer Systems Validation (CSV)

17. WhatWillYouWrite? CSV Kits Validation Plan Requirements Specifications Design Documents Test Plans Test Scripts Implementation Plans Test Summary Report Validation Summary Report

18. WhatWillYou Do inRegulatoryPublishing? Build the modules in the electronic common technical document (eCTD) submission Module 1 Administrative Information Module 2 Summaries Module 3 Quality Module 4 Nonclinical Study Reports Module 5 Clinical Study Reports

19. WhatWillYouPublish? Publish Modules 1 – 5 with software tools such as ROSETTA regulatory software PharmaReady™ eCTD Office LiquentInSight MasterControl/DatafarmGxP2eCTD Connector

20. What Can You Do toTransition? Prepare Decide whether the three interests are you Refresh your science background Know your skills Use 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 skills Network with people in target organizations to uncover work Use LinkedIn (and the other social networks) to find people in target organizations Count on the fact that people will help you

22. How Can You Leverage? On the contract / job Learn the organization and its many groups Be prepared with a 30-second elevator speech Introduce yourself at the coffee area, in the elevator Seek out and introduce yourself to employees who might use your services Make an effort to meet groups that could use your services

23. Another Viewpoint Read LinkedIn Society 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 You Bill Gruener bill@billgruener.com