Regulatory Submissions Publisher

£40000 - £41000 per annum
  1. Permanent
  2. Publishing & Submissions
  3. United Kingdom
Kent, England
Posting date: 12 Apr 2021

An exciting opportunity has arisen for a Regulatory Submissions Publisher to create Regulatory Submission Dossiers for Clinical trials, marketing authorisation approval and or pharmaceutical products. This role is based in Kent, working remotely.

Job Responsibilities

  • Responsible for the building, publishing and associated tasks for assigned Regulatory submissions within agreed timelines.
  • Administrative activities such as tidying and reducing backlogs on the submission file shares and maintenance of publishing systems
  • 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

Skills and Requirements

  • 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.