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 to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.
Requirements
- Authors complex clinical documents for timely submission to health authorities worldwide according to good documentation principles and consistency between text and tabular presentations or graphical displays
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents
- Use document development tools that incorporate artificial intelligence, structured content, programming features, and other evolving approaches to enhance efficiency, quality, and speed of processes
- 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
- 401k Matching
- Retirement Plan
- Generous Paid Time Off
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
- Health insurance
- Disability insurance
- Life insurance
- Paid time off
- Holidays