Senior Manager, Global Scientific and Regulatory Documentation

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.

Requirements

• Authors complex clinical documents such as Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries.
• Use document development tools that incorporate artificial intelligence, structured content, programming features, and other evolving approaches to enhance efficiency, quality, and speed of processes.
• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Review and edit documents as required.
• Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.

Benefits

• Competitive benefits, services, and programs
• Opportunities for growth and development
• Hybrid work model
• On-site Protocol
• Support for people with disabilities