Over the past few months, I’ve had a lot of conversations with VP-level and senior medical writing and regulatory leaders across large pharma organisations. A year ago, many of those conversations still centred on whether pharmaceutical organisations should invest in AI for medical writing at all. That debate is largely over. Most large pharma teams are already running pilots, contributing to enterprise-wide innovation programmes, and actively evaluating where different technologies fit. The...

Over the past six months, conversations with senior medical writing and regulatory leaders across large pharmaceutical organizations have begun to converge around a clear and consistent message. Despite the rapid rise of Generative AI, enthusiasm inside regulated environments is becoming more measured. What is emerging is not resistance to AI, but a more mature, risk-aware understanding of where different technologies genuinely belong. This shift closely mirrors the direction set out in the...