Principal Medical Writer

Job Summary

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

Key responsibilities

• Organize, analyze, interpret, and present scientific and statistical information in compliance with regulatory guidelines
• Lead internal project teams in the development of submission-level documents for health authority approval
• Provide subject matter expertise for quality document preparation and review processes

Required qualifications

• Bachelor's degree; MS or PhD preferred
• 7+ years of regulatory writing experience, particularly with nonclinical sections of the CTD
• Strong understanding of regulatory authority guidelines and the drug development lifecycle
• Experience in developing submission-level documents
• Intermediate proficiency in Microsoft Word and document management techniques