Regulatory Insights: Jam Session for Regulatory Medical Writers in Phoenix

Abstract

This article summarizes key insights from the inaugural jam session for regulatory medical writers held at the 2025 AMWA Medical Writing & Communication Conference in Phoenix. Midlevel professionals from pharmaceutical and medical device sectors gathered to discuss the evolving roles, responsibilities, and challenges faced by regulatory writers. The session highlighted the collaborative nature of their work, which spans authoring a diverse range of regulatory documents to support clinical development milestones. Participants addressed issues with current systems and tools, emphasizing the need for unified platforms and more efficient document management processes. The integration of artificial intelligence (AI) was a focal point, with writers expressing caution about its current limitations for regulatory writing, noting the importance of human oversight, and recommending strategic use of AI for specific tasks. The group underscored the critical value regulatory writers bring to teams beyond document preparation, including study design input, data interpretation, project management, and team leadership. Concerns were raised about the underappreciation of writers’ scientific expertise by cross-functional teams, with a call for greater advocacy and early involvement. Writers also reflected on the rewarding aspects of their roles and shared success stories in process standardization and cross-team collaboration. Finally, the article discusses industry shifts, the importance of resilience, and strategies for preparing a versatile and empowered workforce to address future challenges to maximize the impact of regulatory medical writers across the product lifecycle.