Optimizing the Value of Regulatory Medical Writers

Abstract

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly recognized. The American Medical Writers Association (AMWA) formed a working group in 2020 dedicated to defining the value that regulatory medical writers contribute. The purpose of this article is to demonstrate the value that regulatory medical writers bring to the drug development and approval processes and to explore the ways in which efficiencies in regulatory writing can be increased. Current models for success provide guidance on training to help medical writers achieve their full potential, but obstacles and barriers to medical writing efficiency and document quality remain. Surveys developed by the AMWA working group revealed that (1) regulators who review clinical documents believed that regulatory writers improve document quality and (2) writers are frequently recognized for leadership and collaboration. Maximizing medical writing value requires thoughtful leadership and investment in training that includes both technical knowledge and soft-skill proficiency.