Athens, Greece
Lisbon, Portugal
Brussels, Brussels-Capital Region, Belgium
Belgrade, Serbia
Barcelona, Spain
London, United Kingdom
Madrid, Spain
Full time
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The FTE Medical Writer will serve as an integrated member of the team, delivering medical writing services for the development of clinical documents, including Clinical Trial Reports (CTRs), Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and CTP amendments, Briefing Books, Investigator's Brochures (IBs) and IB updates, Biomarker Reports, and submission documents such as the Summary of Clinical Efficacy and Safety, etc. Emphasis will be placed on the therapeutic areas of eye health and inflammation;
senior-level experiencein these areas is preferred.
The FTE Medical Writer will work on a dedicated basis and be embedded in sponsor's processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions.



The FTE Medical Writer will adopt sponsor's systems, tools, and methodologies to ensure seamless collaboration and alignment with internal teams.
Tasks typically include, but are not limited to:
- Document management: Set-up and management of clinical document in the Electronic Document Management System (EDMS)
- Review and approval of the Statistical Analysis Plan in the EDMS
- Management of timelines including proposal of timelines to trial/project team (based on timelines communicated by sponsor), finalising them after agreement, and updating them as appropriate
- Preparation for and attendance of the required trial team meetings or submission meetings
- Preparation, conduct, and documentation of kick-off meetings, e.G. for TDO/CTP, IB or CTR writing
- Preparation, conduct, and documentation of Results Alignment Meetings (RAM; not applicable for Phase I in healthy volunteer studies)
- Writing of drafts including appropriate in-text tables

📌 Senior Medical Writer — Remote Spain (Chamartín)
🏢 Precision Medicine Group
📍 Chamartín