About this role
Responsibilities
- Author comprehensive safety assessment reports (including signal evaluations), ensuring scientific accuracy, clarity, and regulatory alignment
- Prepare and draft high-quality responses to FDA Information Requests as needed
- Prepare and draft core safety reference information or justification for safety sections of the label
- Prepare and draft slides for safety related presentations for both internal and external meetings, including FDA advisory committee meeting.
- Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses
- Contribute to risk-benefit analyses, RMP writing, and other safety sections required for various clinical and safety documents (IB, CSR, etc)
- Assist in drafting, editing, formatting, and maintaining safety-related SOPs and associated work instructions
- Ensure SOPs align with current regulatory requirements and internal quality standards
- Support inspection readiness activities as needed
Qualifications
- Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific field (doctorate level preferred)
- 8+ years of medical writing/safety scientist experience, with significant focus in safety, clinical, or regulatory documents.
- Experience with writing safety signal assessment documents.
- Prior experience with writing and preparation for FDA advisory committees is highly valued.
- Demonstrated experience drafting responses to FDA Information Requests related to safety
- Strong understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk management
- Proven ability to review and interpret adverse event data
- Familiarity with global regulatory requirements (EMA, PMDA, etc.)