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
Manager, Global Scientific and Regulatory Documentation
Builds
Regulatory submissions and approvals for products in the BMS pipeline
Domain
Global pharmaceutical drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Authoring and managing Investigator's Brochures, Safety Aggregate Reports, Clinical Protocols, and Clinical Study Reports; Analyzing and interpreting complex data from broad scientific disciplines; Understanding global pharmaceutical drug development; Managing timelines and quality of work; Working knowledge of document management systems
Preferred skills
Experience with document development tools incorporating AI and structured content; Experience with document strategy sessions and maintaining document prototypes
Technologies
Document development tools with AI and structured content features; Document management systems
Responsibilities
Coordinate and author regulatory documents ensuring integration of scientific, medical, and regulatory input; Use document development tools to enhance efficiency and speed; Participate in document subteams to manage timelines; Participate in document strategy sessions for messaging and consistency; Maintain document prototypes and shells; Review and edit documents as required
Seniority
Manager, strategic coordination and execution
