Senior CSR Narrative Writer

Job Summary

A company is looking for a (Sr) CSR Narrative Writer to produce high-quality safety documents and patient narratives for regulatory submissions.

Key Responsibilities

• Write safety documents and patient CSR narratives for regulatory agencies
• Manage document revisions and client comments with minimal oversight
• Ensure compliance with ICH and regulatory guidelines while providing excellent customer service

Required Qualifications

• Experience in leading CSR narrative projects, preferably in Oncology
• College graduate in a scientific, medical, or clinical discipline, or related experience
• 1-3 years of experience in a regulated scientific/clinical or pharmaceutical environment
• Understanding of ICH guidelines related to clinical study writing
• Master's or PhD in a relevant field preferred