Senior Associate, Report Publishing and Systems

  • Salary: Competitive
  • REF Number: 00052359
  • Consultant: Ashleigh Williamson
  • Contact: 01438 842 978
  • Date Published: 14.12.2021
  • Sector: Pharmaceutical
  • Location: Hatfield, Home Counties
  • Discipline: Research & Development

CK Group are recruiting for a Senior Associate, Report Publishing and Systems to join a Global Pharmaceutical company. This will be a flexible home-based role anywhere in the UK.

Senior Associate, Reporting Publishing and Systems Role: Providingprimary support for the creation and maintenance of pharmaceutical product related reports such as IMPD's, Protocols, Nonclinical and Clinical study reports. In addition to collaborating with Report Publishing team members, they will be expected tocollaborate with GSM submission managers to ensure the timely delivery of studies required for Global Submissions. They will also be expected to ensure the quality and formatting of each report according to established internal guidelines.

Key duties will include, but not limited to:

  • Ensure availability of submission-ready documents in appropriate quality for lifecycle submissions summarises complex information in an effective manner
  • Interact with strategic partners for publishing
  • Support execution of regulatory report publishing strategy under mentorship and direction of manager
  • Act as report publishing super user and provide expertise to colleagues
  • File preparation and troubleshooting during report publishing activitiesas power user
  • Maintenance of report publishing electronic archive
  • Collaborate with various cross functional stakeholders un the generation and maintenance of SOP's, work instructions, templates, and training materials.

Your Background:- College or University degree preferred but not mandatory, or equivalent

  • Demonstrate experience in Regulatory Affairs Publishing
  • Good knowledge (or capability) of electronic publishing related software programs
  • Demonstrated experience in systems, in relation to document management
  • Previous experience in pharmaceutical industry an advantage
  • Understanding of ICH guidelines and eCTD submissions

Apply: Entitlement to work in the UK is essential. For more information or to applyfor this Senior Associate, Report Publishing and Systems position, please contact Ashleigh Williamson on 01438 842 978 or email awilliamson@ckgroup.co.uk. Please quote reference 52359.iology position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52437.

It is essential that applicants hold entitlement to work in the UK.

IND180

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