Jen Moyers

Nov 22, 2024 | certara.com | Jen Moyers |Danielle Pillsbury

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and involved clearly defined roles. The writers wrote all the non-clinical and clinical documentation, and then the reviewers reviewed it. With the advent of collaborative authoring technology, that process went by the wayside. Initial drafts are frequently written in collaboration with team members who would have previously been classified in a review role.