Description:
The Clinical Central Services function partners with the Business Units and across functional support (Quality, medical, medical affairs, legal, safety, CT supply planning, commercial manufacturing, finance, regulatory etc.) to develop strategies for drug supplies and executes the operational activities required for contracting, planning drug supplies, and managing shipments for researchers and patients worldwide.
The Externally Sponsored Research and Access Programs Drug Supply Coordinator is responsible for the global supply chain coordination of drug supply (clinical trial supply in addition to Lilly commercial products) in support of Investigator Initiated Research (IIR), Expanded Access Programs (EAP), and other ESCR programs. Partnering cross-functionally is key to ensuring the appropriate drug supply products are procured and delivered to meet patient needs around the globe.
Key Responsibilities
- Participate in demand planning and sourcing strategy conversations for externally sponsored research and access programs as needed.
- Provide portfolio visibility and clear traceability at the appropriate level of all commercial products.
- Coordinate externally sponsored research and expanded access upfront processes from contracting through initial shipments.
- Own order fulfilment activities from order placement through material delivery including dating needs, delivery schedule and priorities.
- Establish effective relationships with external industry collaboration partners, clinical trial packaging collaboration partners and distribution sites, Lilly commercial supply chain, and functional areas across the clinical trial packaging organization.
- Coordinate activities and communicate timing on outgoing shipment schedules.
- Troubleshoot and resolve purchasing, material fulfilment and operational level issues as they arise.
- Identify and participate in continuous process improvements to improve productivity, compliance, and data accuracy.
- Identify supply concerns, when appropriate, and help drive action plans.
- Manage material inventories or communicate current inventory status.
- Facilitate demand requirements review with cross functional team and facilitate alignment to a unified plan.
- Author observations, deviations, and change controls, as necessary.
- Serve as point operational contact for supply chain relationships, track key metrics and provide issue escalation, as necessary.
- Utilize QDocs, VaultClincal, TrackWise, CTWIN and other systems.
Minimum Qualification Requirements
- Bachelor’s degree preferred (Supply Chain, Logistics, PharmD, Business) or equivalent work experience.
- Experience in managing inventory/supplies and/or experience managing commercial product or development supply chains
- Experience working with third parties
- Working knowledge of GMP/GDP/GCP regulations.
- Minimum 1-year previous GMP supply chain experience