Safety Writer/Scientist

Job Summary

To support critical regulatory and medical safety documentation activities, the part-time contract Safety Writer/Scientist will prepare high-quality safety regulatory documents, including responses to FDA Information Requests and safety assessment reports, while working remotely.

Key responsibilities

• Author comprehensive safety assessment reports, ensuring scientific accuracy and regulatory alignment
• Prepare and draft responses to FDA Information Requests and core safety reference information
• Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses

Required 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, focusing on safety, clinical, or regulatory documents
• Experience with writing safety signal assessment documents
• Prior experience with writing for FDA advisory committees is highly valued
• Strong understanding of pharmacovigilance principles, including adverse event reporting and risk management