Optimizing the Value of Regulatory Medical Writers
DOI:
https://doi.org/10.55752/amwa.2021.82Abstract
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.
Downloads
Published
How to Cite
Issue
Section
License
Copyright Notice
Authors of manuscripts accepted for publication retain copyright in their work but are required to grant to AMWA exclusive worldwide first publication rights and further grant a nonexclusive license for other uses of the manuscript for the duration of their copyright as outlined in the Agreement on Authors' Rights and Responsibilities. In the same agreement, authors are required to confirm that the material submitted for publication, both in its paper and electronic versions, including reproductions of other works (eg, photographs, maps, etc.) does not infringe upon any existing copyright.
Any reproduction within two years following the date of publication requires the permission of the Editor-in-Chief of the AMWA Journal.
Contact managingeditor@amwa.org for all requests for reuse.