Principal Medical Writer
Job Summary
Independently planning and preparing regulatory documents and medical communications, the full-time Principal Medical Writer will support all phases of product development while working remotely and collaborating with cross-functional teams.
Key responsibilities
- Organize, analyze, interpret, and present scientific and statistical information in accordance with regulatory guidelines
- Collaborate with internal and external document production teams to ensure high-quality deliverables
- Maintain compliance with International Council for Harmonisation (ICH) and company document standards
Required qualifications
- Bachelor's degree required, preferably in a science-related field
- 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 skills in Microsoft Word
- Strong interpersonal and communication skills
Complete Job Description
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