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