Sr Specialist – Clinical Distribution
Current• Executed project plans for the packaging and labeling of standard/ non-complex open label US and/or EU clinical trial supplies. • Train and assist coworkers in the use of new software packages as well as testing of new versions for organizational rollout. • Participate in various projects to help ensure process, quality, and data integrity throughout the organization. • Coordinates the project plan with the CMO to ensure clinical supply timelines are achieved. Facilitate (WIP) meetings and coordinates with Groups to review relevant topics. • Assist in developing and communicating accurate lead time requirements to our packaging/distribution vendors. • Work with Clinical teams to assure on time site shipments through updated study forecast . • Contributes to the preparation and distribution of periodic status reports on planned packaging and shipping.• Create and transact lot and batch request in oracle as well as execute transfer and shipping request through various company-based logistics systems.• Assist and provides timely and accurate information in the maintenance of the Electronic Data Capture inventory databases such as (WIP) and Veeva vault docs. • liaison between Seagen clinical teams and QA to Update SPECs to appropriate regulated requirements.