Senior/ Medical Writer

Overview

As a senior Medical Writer, you collaborate closely with sponsor teams to develop clinical documents (CTRs, TDOs/CTPs, IBs, RAMs, Biomarker Reports, submission materials) in eye health and inflammation. You are embedded in sponsor processes, shaping timelines, documents, and review cycles to ensure regulatory alignment. You will lead writing for complex documents, contribute strategic input, and ensure quality and consistency across submissions. This role offers impact through integrated collaboration and direct contribution to regulatory documents and publications.

Responsibilities

• Set up and manage clinical documents in the EDMS
• Review and approve the Statistical Analysis Plan in the EDMS
• Propose and finalize trial/project timelines; monitor and update as needed
• Prepare and attend trial team and submission meetings
• Lead kick-off, RAM, IB/CTR writing, and related documentation activities
• Draft documents with appropriate tables/figures and manage all review cycles
• Oversee QC checks and complete QC documentation
• Deliver final documents to trial/project teams and initiate publishing and pre-archive checks
• Ensure e-approval of final clinical documents in the EDMS
• Perform technical checks on IBs/IB updates and follow sponsor SOPs

Key requirements

• Bachelor’s degree in a scientific, clinical, regulatory, or related field
• Approx 5 years of medical writing experience in biopharma, biotech, or CRO
• Strong knowledge of global regulatory requirements (ICH, FDA, EMA)
• Broad understanding of clinical research processes and regulatory submissions
• Demonstrated ability to lead writing for complex documents and provide strategic input
• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to work cross-functionally and independently
• High attention to detail and scientific accuracy
• Proficiency in Microsoft Word and document formatting
• Experience with electronic document management systems (eDMS) and templates/style guides/structured authoring tools

• cross-functional collaboration
• attention to detail
• time management
• Microsoft Word
• EDMS/eDMS
• document formatting best practices

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