Principal Medical Writer

IQVIA seeks an experienced Principal Medical Writer to lead development of clinical and regulatory documents for global submissions. The role involves directing medical writing activities across multiple programs, providing strategic guidance to cross-functional teams, and ensuring compliance with international regulatory standards.

Responsibilities

• Lead development of clinical and regulatory documents including IBs, CSRs, and marketing authorization submissions
• Oversee medical writing activities across multiple compounds and provide strategic guidance to teams
• Manage medical writing projects including planning, timelines, resource coordination, and deadline delivery
• Mentor other medical writers and ensure scientifically sound, consistent deliverables across projects
• Develop and refine SOPs, templates, and best practices while staying current with regulatory requirements

Requirements

• Bachelor's degree in scientific, clinical, regulatory, or related field; advanced degree preferred
• 7+ years medical writing experience in biopharmaceutical, biotechnology, or CRO settings
• Deep knowledge of global regulatory requirements (ICH, FDA, EMA) across clinical development phases
• Strong understanding of clinical research processes, study design, and regulatory submissions
• Demonstrated leadership ability for complex document development and cross-functional collaboration
• Excellent written and verbal communication skills for complex scientific information
• Strong project management, organizational skills, and ability to manage multiple priorities

Compensation: $84,400.00 - $211,100.00 base pay