Berkshire (Home Working)
Up to £60 p/h
I am working with a global biopharmaceutical who are looking for an individual to provide comprehensive strategic and operational support to ensure regulatory approval and compliance for clinical trials conducted in specified regions e.g. Western Europe (WE) and Eastern Europe Middle East and Africa (EEME&A), Latin America (LA) & Japan and Asia Pacific (JAPAC) region
- Work with the Global regulatory lead and other cross functional contacts responsible for development compounds with strategic and operational advice for clinical trials
- Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities; substantial amendments, end of trials notifications etc.
- Liaise with key contacts in Regulatory Affairs, Clinical Study Management, Clinical Operations, Supply Chain and local affiliates to identify & resolve issues
- Input into CA response to questions/requests for information
- Support inspection readiness activities when applicable
- Ensure approved company CTA processes are followed within agreed timelines
- Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met
- Monitor key project milestones, communicate changes to assigned stakeholders and management as agreed in company procedures
- Support SOP reviews and updates as required
If you are interested about this position and would like to know more, then send your CV to firstname.lastname@example.org.