Hobson Prior are looking for a Medical Writer to join a leading pharmaceutical research company to join them on a contract basis in Belgium.

Job Responsibilities:

• Contribute optionally in CST and other strategic meetings (when relevant), as Medical Writing Leader representative, and closely interact with Medical, Regulatory, Biostatistics, Clinical Operations and other functional representatives.
• Provide scientific and writing expertise during the development of clinical documents and ensure that these documents meet all of the organisation's standards and regulatory requirements.
• Supervise timelines, meetings, and overall quality of the clinical document.
• Represent as the first point of contact for the CRO medical writer, in case of outsourcing.
• Provide sufficient background information and instructions to the CRO medical writer.
• Support the writing of Study Outlines.
• Organize kick-off and review meetings for the clinical documents and ensure meeting minutes are documented.
• Write Clinical Study Reports, Clinical Study Protocols and revisions, Pediatric Investigational Plan, Clinical Overviews, and Clinical Summaries with the CST.
• Write the Investigator's Brochures, in close collaboration with the section owners.
• Write Scientific Advices, Briefing Books, and responses to questions from Authorities, in close collaboration with Regulatory.
• Actively participate in MWR and Biometrics team meetings.
• Adherence to existing Policies and Procedures and ensure timely completion of relevant training.

Requirements:

• A minimum of 3+ years in medical writing.
• Experience in writing clinical study reports, regulatory submissions and writing clinical protocols.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.