Regulatory Document Coordinator
6 days ago
Bristol-Myers Squibb is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking an experienced Regulatory Document Coordinator to join our team.
About the RoleThe successful candidate will be responsible for coordinating and authoring complex regulatory documents required for regulatory submissions, ensuring timely submission to health authorities worldwide. This role requires strong writing and analytical skills, as well as excellent organizational and communication skills.
Key Responsibilities- Coordinate and author complex regulatory documents needed for regulatory submissions, such as protocols, pivotal phase 3 CSRs, CTD summary documents, risk management plans, pediatric investigational plans, advisory committee brochures, and responses to health authority queries.
- Participate in relevant document subteams and ensure effective planning and management of timelines for all components of assigned documents.
- Serve as a liaison for external documentation support (when required), prepare specifications for the work, and ensure maintenance of good documentation principles as well as BMS documentation standards.
We offer a competitive salary of $130,000 - $190,000 per year, depending on experience. Our benefits package includes health insurance, retirement plan, paid time off, and opportunities for career growth and development.
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