Regulatory Submissions Publisher 20858-1

Regulatory Submissions Publisher 20858-1
  • Competitive
    HOUR
  • Temporary
  • Kent, England, UK Kent UK CT13 9NJ
Job Ref: J2159852
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 08 April 2021
SRG have a 12 month contract for a Regulatory Submissions Publisher to be based in Kent post COVID.

Job Title: Regulatory - Submissions Publisher

Job Description: Role Purpose:

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 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 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
  • Administrative activities such as tidying and reducing backlogs on the submission fileshares and maintenance of publishing systems
  • Adhere to compliance standards

Training and Education Preferred

  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
  • Functional and technical knowledge and skills to do the job at a high level of accomplishment

Prior Skills/Experience Preferred

  • Proven technical aptitude
  • 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

SRGTalent
08/05/2021 14:03:36
GBP Hour
Contact Consultant:
Natasha Rollason

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