Senior Medical Writer (Eye Health & Inflammation)

About the role

IQVIA is looking for a full-time Medical Writer based in Athens to deliver medical writing services for clinical documents, with emphasis on eye health and inflammation. The writer works on a dedicated basis, embedded in the sponsor's processes and workflows, including feedback and alignment meetings, and takes part in project planning, discussions and training.

Key responsibilities

• Write clinical documents such as Clinical Trial Reports, Trial Design Outlines/Protocols and their amendments, Briefing Books, Investigator's Brochures and IB updates, Biomarker Reports, and submission documents like the Summary of Clinical Efficacy and Safety
• Manage clinical documents in the Electronic Document Management System (EDMS), including reviewing and approving the Statistical Analysis Plan
• Prepare and attend trial team and submission meetings, and run kick-off and Results Alignment meetings
• Write drafts with tables and figures, manage review cycles, integrate changes and complete the Review Documentation Form
• Run Quality Control checks and complete the Quality Control Documentation Form
• Finalise documents, run publishing and pre-archive checks, and approve the final document in the EDMS

Required profile

• Bachelor's degree in a scientific, clinical, regulatory or related field; advanced degree preferred
• Approximately 5 years of medical writing experience in biopharmaceutical, biotechnology or CRO settings; equivalent clinical or preclinical development experience considered
• Strong knowledge of global regulatory requirements (ICH, FDA, EMA) and clinical research processes
• Ability to lead writing of complex documents and work independently in a cross-functional team
• Attention to detail, quality and scientific accuracy

Required skills

• Microsoft Word and document formatting best practices
• Electronic document management systems (eDMS)
• Familiarity with document templates, style guides and structured authoring tools