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Regulatory Documentation Scientist

Hertfordshire, United Kingdom

  • Salary: £35-£40 per hour
  • Job type: Interim/Contract
  • Posted: 27/06/2019
  • Contact name: Ben Gardner
  • Contact number: 03335777578
  • Ref: 4470

Job description

Hobson Prior are currently recruiting for two Regulatory Documentation Scientists for a 12-month contract based in Hertfordshire. You will join a top pharmaceutical organisation who focus on finding better ways to prevent, diagnose and treat diseases by researching and developing pioneering medicines.

Job Responsibilities:

  • Prepares regulatory documents in accordance with appropriate regulatory guidelines/company standards/SOPs, ensuring high scientific quality and consistency with other documents where appropriate.
  • Communicates with document contributors to gather information including Licensing partners where relevant.
  • Plans and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate.
  • Reviews documents for organization/clarity/grammar/scientific standards/internal consistency.
  • Manages the review process, including leading/coordinating adjudication of review comments and incorporating review comments.
  • Apply knowledge of company and regulatory guidelines, procedures and best practices across relevant documents.
  • Make sure that documents are published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory.
  • Contributes to best practices and continuous improvement within Regulatory Documentation.

It is essential to have experience working with these following documents:

  • Clinical Safety Reports
  • Investigator Brochures
  • PSUR’s
  • DUR’s
  • TBRER’s
  • Risk Management Plans

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.