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| Job Location | London |
| Education | Not Mentioned |
| Salary | £369.00 - £455.00 per day |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Contract, full-time |
*Senior Medical Writer - 12-month contract - Pharma - Remote or Office* My client a top Bio-pharmaceutical company has a need for a Senior Medical Writer to join their team on an initial 12 month contract.Within this role the Contract Medical Writers key responsibility will be to lead the preparation of and author scientific/regulatory documentation to support global regulatory submissions. You will interpret complex data and understand and provide guidance on document strategy to develop key messages that support delivery of target labels and minimise regulatory questions.RESPONSIBILITIES* 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) * Lead small regulatory submissions, including development and management of document timelines and resource planning * Author components of moderate/high complexity regulatory submissions* Provide guidance to less experienced writers or other contract medical writers, as appropriate You will 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. In order to be considered for this role, you will possess a Life Science Degree.You will have experience as a Medical writer within the Pharmaceutical Industry with experience 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. Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on Required skills
Keyskills :
Pharmaceutical Medical writing IBs clinical/regulaty documents Phase 1 to 4 CSRs CTD summaries/overviews PIPs/PIP modifications regulaty responses