Trial Supply Manager
Newark Metro Area, New Jersey
This position manages the distribution logistics for assigned projects. The position applies the distribution plan and schedule in the most efficient and competitive way within the agreed timelines and meeting the internal or external customer requirements. The incumbent will coordinate efforts within the global distribution organization. This activity supports the efforts of the larger, global Clinical Supplies Scientific Core Platform and R&D effort. This role will lead or assist in the implementation of improvements in distribution strategy, quality, regulatory compliance, cost effectiveness and efficiency. Duties: - Contribute to the development and apply the distribution strategy (for IVR and non-IVR studies) that ensures continuity of IP at depots and investigational sites. Ensure adequate IP stock at depot and site levels. As necessary, support relabeling activity or transfer of IP between various sites. - Ensure all critical parameters are considered for every distribution strategy; IVRS/IWRS specifications (e.g. initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage or country specific requirements. - Generate and/or review IP shipment requests for accuracy & completeness prior to issuance. Ensure accuracy of IP receipt for all shipments and availability in IVR for applicable studies. - Serve as point of contact for all contracted distribution activities. Provide adequate communication and documentation (including customs values) relevant to the distribution plan and the movement of all investigational products. - Contribute to the quotation for customers' distribution projects to include budgeting and forecasting. - Generate and maintain data for distribution metrics. - Offer creative solutions/proposals to optimize the distribtuion supply chain.
Excellent knowledge of business units, scientific core platforms and interfaces, clinical study protocols and IP related activities with particular emphasis on global distribution and strategy Thorough understanding of GMP & GDP (IP production and distribution) Thorough understanding of IVR/IWR systems Good understanding of CMC and clinical study conduct activities Excellent ability to interface with customers and distribution partners (couriers, brokers, vendors) Excellent oral and written communication skills High attention to detail Excellent negotiation skills Strong problem solving skills Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills Excercises calm, sound constructive judgment during high demanding situations Ability to organize and lead meetings. xperience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required.
Bachelor of Science degree (BS) in Health Science or related discipline and at least 3 to 5 years experience in pharmaceutical business experience required. The individual must be well versed in all aspects of the clinical supply chain process, GMP, GDP and other regulatory requirements as they pertain to investigational products.