Value of Medical Writing: The Regulatory Writer’s Perspective

Abstract

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working group developed a survey designed to gather information about the value that regulatory writers represent. The survey was targeted to regulatory medical writers, included 25 questions, and was administered by using SurveyMonkey. A total of 548 responses were received, and 522 of the respondents were active regulatory medical writers. The survey revealed that writers felt most valued when they were consulted or had their opinion sought (n = 154, 30.8%), contributed to patients and the community (n = 89, 17.8%), and were well compensated (n = 80, 16.0%). Writers felt that their most valuable contributions to document preparation were clarity (n = 196, 44.1%) and organization (n = 80, 18%). Although most writers indicated that their employers provided sufficient opportunities for training and advancement (strongly agree, n = 131, 29%; agree, n= 197, 44.1%), writers also indicated they would benefit from additional training in leadership skills, project management, and collaborative skills/diplomacy. This insight is invaluable for shaping the future of the regulatory writing profession.