Regulatory Document Specialist Lead

5 days ago


Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time
Senior/Principal Medical Writer

We are currently looking for a Senior/Principal Medical Writer to join our team in the UK. As a key member of our clinical development team, you will be responsible for producing high-quality regulatory documents for the international pharmaceutical industry.

About the Role:

  • You will prepare a variety of clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures, as the lead writer in collaboration with client authoring teams.
  • You will ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of our clients.
  • You will provide document-specific advice to clients and oversee other writers and QC specialists assisting on documents under your responsibility.

Requirements:

  • At least 3 years of experience actively writing regulatory documents.
  • Experience as the lead writer on at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs.
  • For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers.
  • Excellent communication skills and the ability to interact directly with clients or authors of documents.
  • Competency in the use of document management systems and review tools.

What We Offer:

  • A competitive salary of $90,000 - $120,000 per annum, depending on experience.
  • The opportunity to work on a wide range of projects and develop your skills and expertise.
  • A dynamic and supportive team environment.


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