Digital tools, from structured content authoring and collaborative review platforms to automated reference management and generative AI, offer the potential to improve the speed and quality of regulatory sub missions. Yet digital innovation in regulatory writing often stalls, not because of the technology itself, but because teams are slow to change how they work. Medical writers (MWs), who lead submission documents across cross-functional teams, are uniquely placed to drive this change.
This article explores why transformation efforts in regulatory submissions often lose momentum when the human element is overlooked, and how MWs can influence change at individual and team levels using an established framework.