Safety Writer/Scientist – Contract

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.)