Job Description
- The Clinical Supply Specialist is responsible for supporting clinical supply managers/leads in developing a robust clinical supply planning and execution function and capability for the client's rapidly growing and dynamic clinical pipeline.
- Reporting to the Director, Global Clinical Supply and being part of the PDCS-CSM (Product Development and Clinical Supply – Clinical Supply Management) team, this position will be responsible for task-based activities within clinical supply chain, packaging/labeling operations, distribution, and systems support.
- Support clinical supply managers in ensuring clinical supply timelines for assigned clinical studies are met.
- Direct/oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
- Support clinical supply managers to ensure all documentation required to set up packaging and labeling activities in time for study start is created. Support clinical supply managers with preparation for resupply packaging and labeling operations.
- Create shipment orders and liaise with external distribution vendors to ensure shipments are processed correctly and delivered on time; resolve any issues with shipments as needed.
- Ensure required import/export documentation is provided for shipments as needed.
- Maintain inventory management for assigned projects by interfacing with vendors to ensure that inventory systems are kept up-to-date, and that final product reconciliation is accurately completed.
- Be part of the Clinical Supply Management team to ensure operational performance is being achieved and improvement initiatives are being delivered, including ownership of smaller initiatives.
- Gather documentation for quality related activities as necessary (CAPAs, deviations, change controls)
- File documents in eTMF and conduct PQCs.
- Possibility of quarterly travel to the Boston office
- BS/BA degree in supply chain/logistics or pharmacy/drug development discipline or equivalent qualification
- 1-3 years of experience in a (clinical) supply chain / logistics environment
- Familiarity with pharmaceutical/clinical supply chain environment
- Desire to increase knowledge within clinical supply chain area.
- Good planning, organizational and analytical skills
- Ability to prioritize and meet deadlines.
- Strong diligence
- Strong and clear communication skills
- Proficiency with personal computers and Microsoft Office Products, including Word, Power Point, and Excel
- eTMF experience
- Clinical supply management
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