Open AccessValue of Medical Writing: The Regulator’s Perspective
Author(s) -
Julia Cooper,
Lisa Chamberlain James,
Joan Affleck,
Brian Bass,
Julia Forjanic Klapproth,
Dylan Harris
Publication year - 2021
Publication title -
american medical writers association amwa journal
Language(s) - English
Resource type - Journals
eISSN - 2163-5315
pISSN - 1075-6361
DOI - 10.55752/amwa.2021.83
Subject(s) - perspective (graphical) , quality (philosophy) , value (mathematics) , regulatory agency , agency (philosophy) , process (computing) , public relations , business , medical education , political science , medicine , sociology , computer science , public administration , social science , philosophy , epistemology , machine learning , artificial intelligence , operating system
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.