Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer - Regulatory & Publications.

Key Responsibilities

• Prepare and develop high-quality regulatory and publication documents, including clinical study reports and study protocols
• Lead project team meetings and provide direction on document content and strategies
• Ensure compliance with regulatory standards and mentor less experienced medical writers

Required Qualifications

• Bachelor's degree in a science-related field with 7+ years of relevant industry experience, or a master's degree with 5+ years of experience in medical writing or related areas
• Experience in NDA submissions and writing regulatory documents such as CSRs and IBs
• Proven experience writing scientific medical publications, including journal manuscripts and abstracts
• Strong scientific background in oncology, immunotherapy, or a related field
• Proficient knowledge of AMA writing guidelines and extensive knowledge of FDA, EMA, and ICH guidelines