Contract Safety Writer

Job Summary

A company is looking for a Safety Writer - Contract.

Key Responsibilities

• Author comprehensive safety assessment reports for BLA submissions, ensuring scientific accuracy and regulatory alignment
• Prepare and draft responses to FDA Information Requests related to BLA safety content
• Collaborate with various teams to ensure consistency and completeness of safety narratives and analyses

Qualifications

• Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific field
• 8+ years of medical writing experience, with a focus on 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 and global regulatory requirements