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| Job Location | Cambridge |
| Education | Not Mentioned |
| Salary | £55,000 - £60,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
CK Clinical are working on an exclusive project to recruit for a Regulatory, Scientific and Medical Writer to join a dynamic and growing organisation that provides specialist consultancy services to a wide range of clients, and who specialise in supporting the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas.This position can offer a combination of home and office-based working in Cambridge.Regulatory, Scientific and Medical Writer Role:We are currently looking for an experienced Regulatory, Scientific, and Medical Writer to join an award-winning team and support the company for further growth. Our client can offer excellent opportunities for your own growth and development via interaction with the their team and their clients on their novel and cutting-edge programmes.Responsibilities:- Preparing a range of documents for submissions in the UK, EU and US such as clinical summaries and overviews, scientific advice briefing documents, paediatric investigation/study plans, orphan drug applications.- Preparing clinical documents (e.g., clinical protocols and protocol synopses, clinical study reports, Investigator brochures).- Preparing abstracts and manuscripts for submissions for scientific conferences and publication in scientific journals.- Registering clients and preparing and uploading data updates, to ensure compliance with local regulations.- Project management/liaising internally and externally, to ensure client timelines are met.- Scheduling and chairing roundtable meetings with clients to address and resolve comments on draft documents.- Support for formatting of all document types, as required.- Support for business development activities, as needed.Your Background:- A self-starter with a proven experience in regulatory/scientific/medical writing within the biotech/pharma sector.- Minimum of a B.Sc. in a Life Sciences subject, although an advanced degree is preferred.- Significant experience in the preparation of key regulatory and clinical documents for complex projects.- Excellent grammatical, editorial and proofreading skills and attention to detail.- Ability to work as part of a team.- Experience of ATMPs is advantageous but not essential.- Confident when interacting with clients and a willingness to take the lead in conversations and suggest a way forward (e.g. communicating timelines, chairing roundtables to resolve conflicting comments from multiple external reviewers).- Ability to assimilate, analyse and present (in writing and verbally) a broad range of data and information.Full job description available upon request.Apply:For more information or to apply for this Regulatory, Scientific and Medical Writer position, please contact CK Group, quoting job ref 50036.It is essential that applicants hold entitlement to work in the UK.