Principal Medical Writer, Clinical Affairs
Job Summary
A company is looking for a Principal Medical Writer, Clinical Affairs.
Key Responsibilities:
- Lead the creation and review of clinical documentation in alignment with global regulatory requirements
- Support clinical strategy and study design, providing input on study plans and protocols
- Act as the Clinical Affairs representative on cross-functional teams, ensuring compliance and expertise in clinical evidence generation
Qualifications:
- Bachelor's degree in a scientific or medical discipline; advanced degree preferred
- 8-12+ years of experience in medical writing or a related field within diagnostics or pharmaceuticals
- Hands-on experience with clinical documentation for regulatory submissions under IVDR or similar frameworks
- Proven ability to manage multiple priorities in a fast-paced environment
- Strong collaboration skills with cross-functional teams
COMPLETE JOB DESCRIPTION
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