Description
The role entails:Compilation, review, submission and maintenance of multiple CTAs for therapy products.
Interaction with US-based CRO regarding submission and maintenance of multiple INDs for gene therapy products.
Interaction with external CRO regarding drafting, review, and submission of DSURs and Orphan Drug Annual Reports.
Design, development, and maintenance of tracking systems for the clinical trial projects, upcoming submissions and future workload, IMP shelf-life, and clinical trial supply inventories.
Management of clinical trial supply, interacting with the QP, Clinical department, Contract Distribution Organisation and clinical trial sites, to ensure timely shipment of IMP supplies to ensure the smooth running of multiple clinical trials in the EU and the U.S.A
If you are interested in this role, please contact Mina Ranavaya on , or alternatively, do send your CV through and I will be more than happy to get in touch. Sthree UK is acting as an Employment Business in relation to this vacancy.