Senior Medical Writer – Scientific Documentation Specialist

About the role

The Senior Medical Writer is responsible for producing high‑quality medical and scientific documents from planning through final delivery. Working closely with internal and external stakeholders, the role supports operational excellence across therapeutic areas.

Key responsibilities

• Author and edit routine documents such as clinical study reports, study protocols, investigator brochures, INDs and MAAs.
• Summarise clinical data and ensure compliance with regulatory guidelines.
• Review drafts prepared by junior writers and provide mentorship on document preparation, software tools, and regulatory requirements.
• Develop best‑practice methods, timelines, budgets and contract modifications for assigned projects.
• 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 experience in pharmaceutical or CRO medical writing.
• Additional qualifications (AMWA, EMWA, RAC) are advantageous.
• Strong knowledge of global and regional document development guidelines.

Required skills

• Medical writing and data interpretation.
• Project management.
• Excellent written and oral communication, including proofreading and presentation.