Senior Manager, Global Scientific and Regulatory Documentation
Core
Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies.
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), managing document timelines, cross-functional coordination, global pharmaceutical drug development knowledge, document management systems
Preferred skills
Experience with AI and structured content tools in document development, document prototyping, resolving inconsistencies in regulatory documents
Technologies
Document management systems, document development tools with AI and structured content features
Responsibilities
Authors complex clinical documents for timely submission to health authorities worldwide, participates in document strategy and prototyping sessions, leads and influences a diverse group of authors without reporting relationship, manages review process and resolves issues to ensure high quality
Seniority
Senior Manager, strategic leadership and cross-functional coordination