Senior Medical Writer – Clinical Documents (Eye Health & Inflammation)

About the role

The Senior Medical Writer will join an integrated team to produce high‑quality clinical documentation for eye health and inflammation therapeutic areas. Working as a full‑time employee, the writer will be embedded in sponsor processes, participating in planning, project discussions, and required training.

Key responsibilities

• Set up, manage, and maintain clinical documents in the Electronic Document Management System (EDMS).
• Review and approve Statistical Analysis Plans within the EDMS.
• Develop timelines, propose schedules to trial/project teams, and update them as needed.
• Prepare for and attend trial team and submission meetings, including kick‑off and results alignment meetings.
• Draft clinical documents (CTRs, protocols, IBs, briefing books, biomarker reports, summary of efficacy and safety) with appropriate tables and figures.
• Manage review cycles, integrate feedback, and complete review documentation forms.
• Conduct Quality Control checks, complete QC documentation, and ensure final document approval in the EDMS.
• Perform technical checks and final formatting before publishing and archiving.

Required profile

• Bachelor’s degree in a scientific, clinical, regulatory or related field (advanced degree preferred).
• Approximately 5 years of medical writing experience in biopharma, biotech or CRO environments.
• Experience in eye health and inflammation therapeutic areas is preferred.

Required skills

• Proficiency with Electronic Document Management Systems (EDMS).
• Ability to review Statistical Analysis Plans.
• Quality Control (QC) review expertise.