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. Provides support for fit-for-purpose regulatory documents (clinical pharmacology, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.

Requirements

• PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 2-4 years of regulatory documentation
• Strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR
• Ability to analyze and interpret complex data from a broad range of scientific disciplines
• Understanding of global pharmaceutical drug development
• Strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team

Benefits

• Competitive benefits
• Services
• Programs