Sr Clinical Supply Operations Specialist
About The Position
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 complex studies as well as long-term departmental and cross-functional projects and on-going 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Requirements
- Fundamental knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partners.
- Fundamental knowledge of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directives
- Proficient in MS Word & Excel
- Efficient Problem Solving
- Excellent Time Management
- Thrives in Ambiguity
- Action Oriented
- Adaptability
- Collaborates Effectively
- Well Organized
- Communicates Effectively
- Detail Oriented
- BS/BA degree in a related field.
- Minimum of 3+ years of experience in the following fields: Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, Manufacturing, Or equivalent research/commercial biopharma experience
Responsibilities
- IP Supply & Inventory Planning: Accountability, Reconciliation, Returns & Destruction (ARRD), Internal System Management including lot creation, batch status, and inventory maintenance, Assessment and Oversight activities (risks, stocking levels, trends)
- IP Shipments: System and Non-system generated Shipments, Depot transfers, Temperature Excursion Management
- IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF): Expected Document List (EDL) creation, eTMF Document Management per regulatory requirements, QA/QP Release Management, Pack-and-label kit and sequence reconciliation, Inspection Readiness activities, IRT management activities including IRT Alert management and UAT activities, Suspected Serious Non-Compliance support
- Ancillary Supply & Inventory Planning/Management: Procurement support (Includes Work Order Management), Vendor RFI support, Supply Planning & Inventory Management, Ancillary Supply Plan creation, Shipping & Logistics (Includes International Logistics requirements for Ancillaries), Shipping & logistics activities, Temperature Excursions, Lot management, eTMF activities, ARRD activities
- Comparator Planning & Management: Market Intelligence Reports, Quote/PO/Requisition Process Support, IMN Creation, Document Storage, Temperature Excursions
- Financial Forecasting, Budgeting & Planning: Forecast Submissions, Order Ticket Entry, Demand Updates
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
