Pharmaceutical Narrative Writer

Job Summary

Responsible for writing safety documents and patient CSR narratives, the full-time remote CSR Narrative Writer will produce high-quality submissions for regulatory agencies while managing client interactions and revisions independently during the document lifecycle.

Key responsibilities

• Write safety documents and patient CSR narratives for regulatory submissions
• Manage client comments, revisions, and ensure compliance with ICH and regulatory guidelines
• Provide excellent internal and external customer service while interacting directly with clients

Required qualifications

• University graduate in a scientific, medical, clinical discipline or related field, or equivalent experience
• Minimum of 2 years' experience in a regulated scientific, clinical, or pharmaceutical environment
• Experience in leading complex CSR narrative projects, preferably with an Oncology background
• Prior medical, narrative, or safety writing experience preferred
• Understanding of ICH guidelines related to medical writing for clinical studies