Senior Manager, Medical Writing

Job Summary

A company is looking for a Senior Manager, Narratives, Medical Writing.

Key Responsibilities

• Write, edit, review, and finalize patient safety narratives based on clinical data
• Manage project timelines and coordinate with study teams and external vendors
• Participate in process improvement activities and ensure adherence to regulatory standards

Required Qualifications

• Advanced degree (MS/PhD/PharmD/MD) in life sciences or related field preferred
• Minimum of 5+ years of narrative writing experience with an MS degree
• Minimum of 3+ years of clinical safety narrative experience with a PhD/PharmD/MD
• Basic knowledge of global regulations (FDA, ICH) and eCTD requirements
• Experience with electronic document management systems and automation tools