Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer.

Key Responsibilities

• Lead complex regulatory and clinical writing initiatives within global product teams
• Mentor junior writers and manage high-profile client relationships
• Author and oversee the preparation of clinical and regulatory submission documents

Qualifications and Requirements

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred
• 4-5+ years of industry experience in clinical trials and lifecycle documentation
• RAC certification preferred but not required
• Advanced knowledge of ICH guidelines, FDA requirements, and global regulatory standards
• Proficiency in MS Project, Word, Excel, Veeva Vault, and Please Review for document and project management