Regulatory, Scientific and Medical Writer

Salary £55-60k

Location Cambridge/home based

We are currently looking for an experienced Regulatory, Scientific, and Medical Writer to join an award-winning. 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
• 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

Please contact Stephanie Maccioni on 01438 768713 or email smaccioni@ckgroup.co.uk, quoting job ref 50036.