Senior Manager, Global Scientific and Regulatory Documentation
Core
Leads document strategy and authoring of message-driven, clear and concise regulatory documents to support submissions and approvals in key markets.
Role type
Senior Manager, Global Scientific and Regulatory Documentation
Builds
Regulatory submissions and approvals for products in the BMS pipeline
Domain
Pharmaceutical regulatory affairs
Required skills
Authoring complex clinical documents (IB, Protocols, CSR, CTD), analyzing complex scientific data, managing cross-functional timelines, understanding global drug development requirements, using document development tools with AI features
Preferred skills
Experience with document management systems, knowledge of document publishing processes
Technologies
Document development tools incorporating AI, structured content, programming features
Responsibilities
Author complex clinical documents for timely submission to health authorities worldwide; Participate in document strategy and prototyping sessions; Lead and influence a diverse group of authors without a reporting relationship; Manage review processes and resolve issues to ensure optimal communication and timely completion; Review and edit documents as required
Seniority
Senior Manager, strategic leadership and cross-functional coordination
