Medical Writing and the Technical Writer

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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, …

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.

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  • 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