Medical Writer - Regulatory Documentation
Hobson Prior currently have an exciting opportunity for a full time Medical Writer (Regulatory Documentation) to join a dynamic team on a fixed-term contract of initially 12 months. Our client is very patient-focused research-based biopharmaceutical company, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them. This position can either be in Uxbridge, Cambridge or remote-based.
- Accountable to plan and independently author core medical writing deliverables for a range of clinical/regulatory documents (eg, Phase 1 to 4 CSRs, IBs, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses).
- Author components of moderate/high complexity regulatory submissions.
- Lead small regulatory submissions, including development and management of document timelines and resource planning.
- Offer guidance to less experienced writers or other contract medical writers, as appropriate.
- Work independently, liaising with medical writing team leaders for complex documents or strategic issues.
- You will work collaboratively within cross-functional teams (eg, Regulatory, Clinical Research, Pharmacovigilance, Biometrics, and Virology) to deliver documents on time and per team expectations.
- Excellent communication, organization, and project management skills.
- Well-developed computer skills including proficiency in MS Office (in particular MS Word [advanced]) and document management systems.
- BA/BSc and 7+ years of relevant experience (clinical R&D, regulatory affairs, or related industry/academia).
- A minimum of 4+ years direct experience in a medical writing/clinical submissions environment (pharma/biotech or CRO/agency) including prior experience of being a Senior Medical Writer.
- Excellent technical writing with demonstrated success in the preparation of clinical/regulatory documents at the individual study report (Phase 1 through 3) and submission level (CTD summaries and overviews, responses to questions/requests for supplementary information).
- Direct experience with IBs/IB updates would be preferable.
- Knowledgeable of regulatory document requirements/guidelines.
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.