Electronic Submission Specialist in Uxbridge

  • Salary: Up to £34.40 per hour
  • REF Number: 00044820
  • Consultant: Hendre Moolman
  • Contact: 01438 842970
  • Date Published: 25.02.2019
  • Closed Date: 11.03.2019
  • Sector: Non-Specific
  • Location: South East, London, Home Counties
  • Discipline: Regulatory Affairs

Hendre Moolman at CK Group is recruiting for an Electronic Submission Specialist to join a pharmaceutical company at their site based in Stockley Park (Uxbridge) on a 6 month contract basis.

The Company: A global biopharmaceutical company who are committed to helping patients who are living with a wide range of debilitating and chronic diseases, from cancer to psoriasis.

The Role: The main purpose of the role will be to:

  • Support Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDS/NDAs/MAAs.
  • Create, assemble, publish, and verification of both major and routine regulatory dossier submissions.
  • Maintenance of all Regulatory and Health Authority submission.

Further responsibilities will include:

  • Verification of regulated electronic documents via workflows within the electronic document management system.
  • Liaise with functional source areas to ensure documents are compliant with authoring style guide.
  • Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.

Your Background: To succeed in this role, you will come from a life science background and proven pharmaceutical industry experience in Regulatory Operations.

  • Experience with compiling eCTD submissions in a publishing tool.
  • Knowledge of health authority procedures/guidance's regarding electronic submissions.
  • Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic.

The Benefits: Your role will be for an initial 6 month period, paying a competitive rate, working for an exciting company.

For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or email hmoolman@ckclinical.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44820 in all correspondence.

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