Senior Medical Writer – Clinical Documentation Specialist

About the role

The Senior Medical Writer leads the creation of high‑quality clinical and regulatory documents, turning complex study data into clear, compliant manuscripts for internal and external audiences. You will act as the primary author for routine and complex documents, ensuring scientific accuracy and regulatory alignment.

Key responsibilities

• Write and edit clinical study reports, study protocols, investigator brochures (IB), INDs, and MAAs.
• Review drafts prepared by junior writers and provide mentorship.
• Collaborate with program managers and cross‑functional teams to develop timelines, budgets, and contract modifications.
• Ensure all deliverables meet quality standards and regulatory guidelines.
• Represent the department in project launch, review, and team meetings.

Required profile

• Bachelor’s degree in a scientific discipline (advanced degree preferred).
• 5+ years of medical writing experience in the pharmaceutical or CRO industry.
• Strong knowledge of global and regional document development guidelines.
• Excellent data interpretation, editorial, and proofreading abilities.
• Proven project‑management and interpersonal skills.

Required skills

• Medical writing
• Clinical documentation (CSRs, protocols, IBs, INDs, MAAs)
• Regulatory submission preparation