Value of Medical Writing—Using the Regulator’s Perspective (2021 Survey Results) to Educate and Empower Medical Writers

Authors

  • Lisa Chamberlain James Trilogy Writing and Consulting, Cambridge, UK
  • Julia Forjanic Klapproth Trilogy Writing and Consulting, Frankfurt, Germany
  • Rona Claire Grunspan Medical Writing, ICON plc, Leawood, KS
  • Wayne Beazley Medical Writing, Astellas, Northbrook, IL
  • Brian Bass Bass Global, Inc, Fort Myers, FL
  • Joan Affleck Medical Writing, Merck and Co, Inc, Rahway, NJ
  • Julia Cooper Global Medical Writing Services, Parexel International (IRL) Limited, Dublin, Ireland
  • Caroline Lilley Regulatory Writing, Amgen, Thousand Oaks, CA
  • Amy Wollish Medical Writing, Jazz Pharmaceuticals, Palo Alto, CA

DOI:

https://doi.org/10.55752/amwa.2023.311

Abstract

In 2021, an American Medical Writers Association (AMWA) working group conducted a survey to gain an understanding of how regulatory agencies perceive the value of medical writing. The survey showed that document quality is extremely important to the timely and efficient review of an application and identified key factors affecting document quality that negatively impact application approval. In response to this, a working group ran a series of roundtables at the AMWA and European Medical Writers Association conferences to gather opinions from medical writers about this survey and how we can best communicate these ideas to authoring teams. This article discusses the feedback obtained in those roundtable sessions and presents the working group’s proposal for a set of resources to empower medical writers to implement change.

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Published

2023-12-12

How to Cite

1.
Chamberlain James L, Forjanic Klapproth J, Grunspan RC, Beazley W, Bass B, Affleck J, Cooper J, Lilley C, Wollish A. Value of Medical Writing—Using the Regulator’s Perspective (2021 Survey Results) to Educate and Empower Medical Writers. AMWA. 2023;38(4). doi:10.55752/amwa.2023.311

Issue

Vol. 38 No. 4 (2023)

Section

Topical Features

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