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Associate, Clinical Services, Supplies

il y a 2 semaines

MontSaintGuibert, Belgique Eli Lilly Temps plein

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose:
The Clinical Services, Supplies & Capabilities (CSSC) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the CDDA and PRD to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.

The Clinical Trial Commercial Product Material Coordinator (CPMC) is responsible for the procurement and global supply chain coordination of Commercial Products (Lilly and non-Lilly) in support of Lilly Trials and Externally Sponsored Clinical Research as well as Expanded Access programs. Partnering with the CT Supply Planning and the clinical organizations are key to ensure the appropriate commercial products are procured and delivered to meet patient needs around the globe. This role will execute CT material sourcing, and labeling requirements for commercial products as required in support of externally sponsored research, Expanded Access Programs, decentralized trial regulations, clinical trial material regulations.

Key Responsibilities
- Participate in demand planning and sourcing strategy conversations as needed.
- Accountable for MRP (Manufacturing Resource Planning) actions from the point of purchase order creation through successful incoming and batch disposition.
- Provide portfolio visibility and clear traceability at the appropriate level of all commercial products.
- Own order fulfilment activities from order placement through material delivery including dating needs, delivery schedule and priorities.
- Establish effective relationships with wholesalers, 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 incoming and 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 supplier relationships, track key metrics and provide issue escalation, as necessary.
- Accountable for oversight of suppliers to support the procurement of Controlled Substances and Lilly Special Security Substances.

Minimum Qualification Requirements:

- Bachelor’s degree preferred (Supply Chain, Logistics, PharmD, Business) or equivalent work experience
- Minimum 1-year previous GMP supply chain experience
- Experience in managing inventory/supplies
- Experience managing commercial product or development supply chains
- Experience working with third parties
- Knowledge of clinical trial packaging
- Working knowledge of GMP/GDP/GCP regulations
- Demonstrated strong and effective written and verbal communication skills in multi-cultural and cross functional settings
- Demonstrated exemplary teamwork/interpersonal skills
- Previous cross functional experiences
- Ability to manage multiple tasks and respond quickly to change
- Ability to build productive relationships and effectively communicate with other Product Delivery team members (Packaging, Quality, Supply Planning. Labelling, etc.)
- Ability to work in an independent, flexible environment
- High degree of accuracy with work and attentive to details
- Ability to proactively identify problems and work toward a solution

Other Information/Additional Preferences:

- Knowledge of Import/Export compliance as it related to clinical trials and shipping medicinal products
- Prior experience in ERP system
- Prior experience with SAP is preferred
- Prior experience with GMP supply chains (wholesaler, manufacturer, CMO)
- Prior experience with Procurement
- Language Requirements: Must be Fluent in English (both written and spoken).
- Additional Information:

- Work outsid