Sr. Clinical Supply Operations Specialist

The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ancillary supplies process and comparator procurement process, for one or more molecules across multiple Therapeutic areas supporting highly sophisticated studies as well as long-term departmental and cross-functional projects and ongoing continuous improvement initiatives. May lead short-term projects. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies.
A typical day might include the following:Solve complex problems, and initiate completion of the following items within broadly defined practices and policies including selecting methods, techniques, and evaluation criteria for obtaining results related to:
IP Supply & Inventory PlanningIP ShipmentsIP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)Ancillary Supply & Inventory Planning/ManagementComparator Planning & ManagementFinancial Forecasting, Budgeting & PlanningThis role might be for you if:You have foundational knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partnersYou are knowledgeable of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directivesYou are proficient in MS Word & ExcelYou can come up with solutions and work in ambiguityTo be considered for this opportunity, we expect you to have 3 years of experience in the life sciences within Clinical Supplies, Regulatory, Quality, Manufacturing or Supply chain. We are also expecting you to have a bachelor's degree. Lastly, we require you to be in our office a few days a week.

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