Description
This role involves authoring complex clinical documents such as Clinical Study Reports (CSR), briefing documents, and Common Technical Documents (CTD) summaries for timely submission to Chinese health authorities. Responsibilities include adhering to good documentation principles, ensuring consistency, and complying with BMS documentation standards and worldwide regulatory requirements. The writer will participate in document strategy and prototyping sessions, manage timelines, and serve as a liaison for external documentation support. They will lead and influence a diverse group of regulatory document authors and explore innovative approaches.
