Principal Medical Writer, Clinical Affairs

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

Apr 8, 2025 - 16:36

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