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