Senior/Principal Medical Writer – Clinical Documents

About the role

The Senior/Principal Medical Writer will lead the creation of high‑quality clinical study documents, ensuring they meet regulatory standards and are delivered on time. This role involves planning, drafting, editing, and finalizing a range of regulatory deliverables while collaborating with sponsors, vendors, and internal teams.

Key responsibilities

• Plan, write, edit, format, and perform QC review of clinical protocols, IBs, ICF templates, DSURs, CSRs and patient narratives.
• Manage document lifecycle from template creation to final approved version in coordination with sponsors and internal project teams.
• Formulate key messages from study data and author complex scientific content.
• Communicate clearly with internal and client teams, both in writing and verbally.
• Contribute to the development and maintenance of medical writing SOPs, templates, and work instructions.
• Perform literature‑based research to support writing activities.
• Identify and solve problems related to document content and formatting.
• Execute other duties as assigned.

Required profile

• BS degree or equivalent in a scientific or medical discipline.
• 5+ years as a Senior Medical Writer in a sponsor/CRO setting or 7+ years as a Principal Medical Writer.
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Strong knowledge of ICH, FDA, GCP regulations, clinical trial transparency requirements (EudraCT, ClinicalTrials.gov) and eCTD submission standards.
• Impeccable attention to detail and ability to meet tight deadlines.
• Ability to work independently in a fast‑paced environment with minimal supervision.

Required skills

• Microsoft Windows
• Microsoft Teams
• Microsoft Word
• Microsoft Excel
• Adobe Acrobat
• Microsoft PowerPoint