Sr Clinical Supply Operations Specialist

Regeneron Pharmaceuticals•Warren, MI

4d•Onsite

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