Temporary, until end of yearTate have partnered with a world leading Pharmaceutical company, to recruit a Submissions Publisher starting ASAP.
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.
- 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 fileshares 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
- Adhere to compliance standards
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
To express interest in this opportunity, please apply today. We look forward to hearing from you.
Please be aware this advert will remain open until the vacancy has been filled. Interviews will take place throughout this period, therefore we encourage you to apply early to avoid disappointment.
Tate is acting as an Employment Business in relation to this vacancy.
your application has been submitted
Back to job search