MEDICAL WRITING AND HIGH TECH WRITERSSTC NNEApril 14, 2010

WhereAre theMedical WritingJobs?

Within one of three groups

•Medical Writing

•IT Organization

•Regulatory Publishing

of organizations that produce health care products

WhoAre TheseOrgs thatDoMedical Writing?

Organizations that must comply with Federal and national laws surrounding the delivery of health care products

WhichOrgsMustComply?

•Producers of products that either

•Touch or•Go into a human body

Part A

WhichOrgsMustComply?

Part B

Handlers of information

•Personally Identifiable Information (PII) in

•Databases•Software tools

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

WhatDoYou Need For Medical Writing?

Curiosity and Regular Involvement with

•Statistics

•Epidemiology

•Biomedical Literature

What IsStatistics?

Science of making effective use of numerical data relating to groups of individuals or experiments

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

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

What Will You Write?

• Submissions (FDA)

• Submissions (EMA)

• Submissions (Health Canada)

• Submissions (Japan Health)

• Submissions (Every EU member)

• Submissions

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

WhatAre theParts of aSubmission?

• 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

• 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 theParts of aSubmission?

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

What WillYou Do InIT?

Write documentation that supports IT quality management systems as outlined in

•21 CFR Part 11

•Computer Systems Validation (CSV)

WhatWillYouWrite?

CSV Kits

• Validation Plan• Requirements Specifications• Design Documents• Test Plans• Test Scripts• Implementation Plans• Test Summary Report• Validation Summary Report

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

WhatWillYouPublish?

Publish Modules 1 – 5 with software tools such as

• ROSETTA regulatory software • PharmaReady™ • eCTD Office • Liquent InSight• MasterControl/Datafarm GxP2eCTD Connector

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

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

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

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

THANK YOUBill Gruenerbill@billgruener.com