Value of Medical Writing: The Regulator’s Perspective


  • Julia Cooper Parexel International, Dublin, Ireland
  • Lisa Chamberlain James Trilogy Writing and Consulting, Cambridge, UK
  • Joan Affleck Merck & Co, Inc, Rahway, NJ, USA
  • Brian Bass Bass Global Inc, Fort Myers, FL, USA
  • Julia Forjanic Klapproth Trilogy Writing and Consulting, Frankfurt, Germany
  • Dylan Harris Takeda Pharmaceutical Company Limited, Lexington, MA, USA



In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s perspective. We invited reviewers at regulatory agencies to participate in an anonymized survey to evaluate the effect of document quality on the regulatory review process, assess awareness among document reviewers of the contribution of medical writers to the quality of regulatory documents, and identify current strengths and opportunities to optimize document quality. This article shares the survey results and discusses their implications for document quality, their impact on the regulatory review process, and the skills medical writers need to develop to bring value to this process.




How to Cite

Cooper J, Chamberlain James L, Affleck J, Bass B, Forjanic Klapproth J, Harris D. Value of Medical Writing: The Regulator’s Perspective. AMWA. 2021;36(4). doi:10.55752/amwa.2021.83



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