The Evolving Role of Medical Writers: AI as a Partner in Regulatory Submissions

Abstract

Medical writers play a crucial role in regulatory submissions, ensuring clarity, adherence to guidelines, and overall document quality. In 2021, AMWA’s working group reported on the value of the contribution of medical writers across the pharmaceutical industry. This included a subgroup tasked to gather data on the perspective of regulatory agencies about the effect of document quality on the regulatory review process, awareness of the contribution of medical writers to the quality of regulatory documents, and the current strengths and opportunities to optimize document quality. This survey confirmed that well-written documents streamline the review process, whereas poor-quality submissions cause delays. With the advent of artificial intelligence (AI), medical writing is undergoing a transformation. This article discusses how regulatory agencies and the pharmaceutical industry may adapt to AI and how the role of medical writers is evolving to integrate technological advancements while upholding the high-quality standards required for successful submissions.