Senior Regulatory Documentation Scientist

  • Salary: Up to £70 phr
  • REF Number: 00054288
  • Consultant: Hendre Moolman
  • Contact: 01438 842970
  • Date Published: 03.10.2022
  • Closed Date: 31.01.2023
  • Industry: Pharmaceutical, Biotechnology
  • Location: Welwyn Garden City/Remote based, London
  • Functional Expertise: Pharmacovigilance

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.

Apply for this job

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.

Read our privacy policy Cancel