Senior Regulatory Writer

The ideal candidate will have a PhD in a biological sciences discipline and 3 to 4 years' regulatory writing experience in medical/regulatory/publication writing in the pharmaceutical/biotech industry, CRO, or medical communications agency. Experience in writing for regulatory submissions to the European or US regulatory authorities is required (e.g., CTD modules, ISS, ISE, scientific advice/briefing documents). Knowledge of the drug development process and understanding of the basic strategy for regulatory submissions is an asset. The right candidate will relish the prospect of a high-profile, client-facing role and the opportunity to deliver a range of regulatory documents as well as mentoring and reviewing work from less experienced Medical Writers. The successful candidate will be part of a team producing a range of high-quality communication items in accordance with the needs of the client. We are looking for a driven and ambitious individual who will embrace our ethos of delivering scientific excellence through collegiate working, open communication and building trusted partnerships with our clients