Author comprehensive safety assessment reports for inclusion in BLA submissions, ensuring scientific accuracy, clarity, and regulatory alignment
Prepare and draft high-quality responses to FDA Information Requests related to BLA safety content
Collaborate with Pharmacovigilance, Clinical, Regulatory Affairs, Biostatistics, and Medical teams to ensure consistency and completeness of safety narratives and analyses
Contribute to integrated summaries of safety, risk-benefit analyses, and other safety sections required for regulatory filings
Ensure documents comply with FDA, ICH, and global regulatory standards
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

Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific field
8+ years of medical writing experience, with significant focus in pharmacovigilance and regulatory submissions
Demonstrated experience writing safety assessment reports for BLAs
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
Experience supporting FDA inspections or regulatory audits
Familiarity with global regulatory requirements (EMA, PMDA, etc.)

Safety Writer – Contract

Key skills