Senior Regulatory Documentation Scientist
CK Group are recruiting for a Senior Regulatory Documentation Scientist to join a pharmaceutical company with a site based in Welwyn on a contract basis for 12 months. Outside IR35
The Role: The main purpose of the role will be to
- Prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety)
- Manage the preparation of regulatory documents, such as Clinical Dossiers and suite of Safety Documents
- Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product and within a clinical dossier
- Prepare specifications for outsourced work, including writing/review of documents, and serve as liaison for projects
- Key documents you will be writing and leading to completion include CSRs, IBs, PSURs, PBRERs, DSURs, RMPs and filing documents such as SCE, SCS and CO.
Your Background: To succeed in this role, you will come from a Lifescience background and previous writing experience, specifically authoring and/or editing regulatory documentation
- Project management as well as an ability to independently evaluate and blend data from a broad range of disciplines
Apply: It isessential that applicants hold entitlement to work in the UK. Please quote job reference 54288 in all correspondence.