Submissions Publisher
ProClinical Recruitment
Sandwich, Kent
33d ago

A leading pharmaceutical company headquartered in the UK is seeking a Submissions Publisher to join their team in Sandwich, UK on a contract basis.

Job Role :

  • This role works within a team to create Regulatory Agency Submission Packages (Dossier) using a number of 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 authorization approval for pharmaceutical products.
  • Main Responsibilities :

  • 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.
  • Support global / local teams publishing teams when the need arises
  • Adhere to company compliance standards.
  • Education and Experience :

  • 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
  • Proven technical aptitude
  • Experience of using various publishing tools such as ISI Publisher 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
  • Apply
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