Principal Medical Writer
Job Summary
Working fully remotely, the full-time Principal Medical Writer will independently plan and prepare regulatory documents and medical communications to support all phases of product development, collaborating with cross-functional teams and adhering to regulatory guidelines.
Key responsibilities
- Organize, analyze, interpret, and present scientific and statistical information in compliance with ICH and company standards
- Collaborate with internal and external teams on document production for various projects
- Prepare a range of regulatory documents to support product development phases
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
- Experience with Microsoft Office Suite is essential, including advanced skills
- Strong interpersonal and communication skills
Complete Job Description
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