Non-Clinical Medical Writer
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Hobson Prior are currently in search for a Non-Clinical Medical Writer to join a global biopharma organisation who are focused on changing the lives of patients living with severe diseases. This role will be based in Braine L'Alleud on a permanent basis.
- Accountable for the preparation of complex documents such as integrated CTD summaries and IBs, and other core medical writing deliverables. May act as primary author or be available to assist the primary authors where necessary.
- Ensures all documents are authored according to regulatory requirements, internal standards, and with adherence to team expectations.
- Integral member of the global submission team and will participate on multiple cross-functional teams. May act as nonclinical representative. Ensures appropriate and effective collaboration with all key submission contributors.
- Assumes responsibility for adhering to timelines agreed within the global submission team and must demonstrate organisational and project management skills to effectively manage all nonclinical contributions.
- Assumes responsibility for the availability of high-quality SEND datasets as required by the Regulatory Agency.
- Acts as an expert in the use of the organisation's authoring tools ensuring accordance with the organisation's writing styles and regulatory submissions specifications, and as expert in the organisation's Electronic Content Management Systems.
- Ensures maintenance of the Nonclinical Medical Writing trackers via a network of internal and external partners.
- A meticulous eye to detail.
- Prove ability to organize/execute multiple projects in parallel, prioritize work and meet milestones/deadlines.
- Service mindset.
- Demonstrate creative yet analytical problem-solving skills to find effective solutions.
- You have a PhD, MSc or BSc in a relevant pharmaceutical development science.
- You have demonstrated awareness (5+ years in an equivalent role) of regulatory requirements for the conduct of nonclinical studies including Good Laboratory Practices and ICH guidelines, relevant regulatory submission guidance documents, and SEND requirements.
- You are proficient in the use of standard software including Microsoft® Excel, Word, PowerPoint, authoring tools (ideally StartingPoint and PleaseReview), and in Electronic Content Management Systems.
- You are confident taking the lead on projects.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.