Section Editors: Clare Chang, Zuo Yen Lee

The AI-enabled medical writer: A new era for regulatory writing
Authors: Jenni Pickett, Vanessa de Langsdorff

As artificial intelligence (AI) becomes increasingly integrated into the pharma ceutical industry, regulatory medical writers find themselves at a critical intersection of science, language, and technology. The traditional approach to document authoring – manual, time-consuming, and highly variable – is being augmented by intelligent automation systems. This article explores how medical writers are navigating this transition, what technological concepts they must grasp to succeed, and how their roles are evolving to collaborate effectively with cross-functional tech teams. The future of regulatory writing is here, and it is structured, standardised, and AI-enabled.