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.

Application Closing Date: 
10 April