Submissions Publisher

Reference: VR-SP-01
Job Type: Temporary
Job Type: Full-time
Location: Sandwich
Start Date: ASAP
Duration: 6 months
Working Hours: 37 hours a week
Salary: £13 per hour
Job Description:

Red Eagle Recruitment (AGY) is looking to recruit a Submissions Publisher for our client, a global pharmaceutical manufacturer based in Sandwich

This role works within a team to create Regulatory Agency Submission Packages (Dossier) using build and publishing tools. The Dossiers are compiled in paper and/or electronic format with documentation received from Hub Submission Managers and submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorisation approval for pharmaceutical products.

Major Duties

  • Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
  • Adhering to quality control procedures and standards related to submission publishing.
  • Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
  • Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
  • Responsible for key projects within a specific region to implement and train on any external agency updates for procedures or requirements
  • Responsible for leading major submissions.
  • Coordinating the allocation of all publishing activities around the global publishing hubs to meet agreed deadlines, whilst tracking and monitoring all issues.
  • Liaising with Global Submission Managers, Hub Submission Managers and contributing lines to discuss and agree expectations and publishing timelines.
  • Monitoring local mailbox for any urgent publishing requests
  • Support global/local publishing teams when the need arises
  • Adhere to compliance standards

Prior Skills/Experience Preferred

  • Proven technical aptitude
  • Experience of using publishing tools such as Liquent InSight and proven knowledge of eCTD formats
  • Quick learner with ability to multi-task
  • Ability to work with accuracy and attention to detail
  • Ability to work with autonomy and/or part of a team in a busy environment
  • Demonstrated ability to work in a highly regulated environment
  • Demonstration of experience working in a customer service environment

This is a 6 month fixed term contract, working 37hours a week Monday to Friday. This is paying an hourly rate of £13 per hour.

To find out more and to be considered for the role of Submissions Publisher, please apply via your CV.


How to apply:

For further information on this vacancy please contact:
Folkestone: 01303 851 133 E-mail: jobs@redeagle.jobs
Please quote the job reference and attach a recent CV if available.



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