Senior Manager, Medical Writing

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