Principal Medical Writer

Job Summary

Working fully remote, the full-time Principal Medical Writer will independently plan and prepare regulatory documents and medical communications, collaborating with cross-functional teams to support all phases of product development.

Key responsibilities

• Organize, analyze, interpret, and present scientific and statistical information in compliance with regulatory guidelines and company standards
• Collaborate with internal and external teams to produce high-quality documentation
• Ensure all written materials meet ICH and other regulatory requirements

Required qualifications

• Bachelor's degree required; science-related field preferred
• Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology setting
• Advanced knowledge of ICH and related regulatory guidelines
• Proficiency in Microsoft Office Suite, particularly advanced Microsoft Word skills
• Strong interpersonal and communication skills