Associate/Sr. Associate/Manager, Clinical Drug Supply, Clinical Trial Commercial Product – Material Coordinator

Job title:

Associate/Sr. Associate/Manager, Clinical Drug Supply, Clinical Trial Commercial Product – Material Coordinator

Company

Eli Lilly

Job description

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 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.At Eli Lilly Cork, 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 45,000 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 patients around the world.Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.Come join our team – Be Creative, Be an Innovator, and most of all, Be Yourself!Purpose:The Clinical Drug Supply (CDS) 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 Clinical Design, Delivery & Analytics (CDDA) and Product Research & Development (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 Clinical Trials, Externally Sponsored Clinical Research, as well as Expanded Access Programs. Partnering with Clinical Trial Supply Planning and other clinical organizations are key to ensure the appropriate commercial products are procured and delivered to meet patient needs around the globe. This role will collaborate to develop and execute CT material sourcing and labeling requirements for commercial products, as required in support of, externally sponsored research, Expanded Access Programs, and decentralized and clinical material trial regulations.Key Responsibilities

• Participate in demand planning and sourcing 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.
• Make quality culture the foundation of your work, to ensure our products are safe and effective to improve patients’ lives.
• Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicate appropriately.

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

Other Information/Additional Preferences:

• Knowledge of Import/Export compliance as it related to clinical trials, clinical trials packaging and shipping medicinal products
• Prior experience with SAP is preferred
• Prior experience with GMP supply chains (wholesaler, manufacturer, CMO)
• Working knowledge of GMP/GDP/GCP regulations
• Prior experience with Procurement
• Educational Degree in Pharmacy, Pharmaceutical Sciences or Supply Chain preferred
• Knowledge of clinical trial packaging
• Ability to build productive relationships and effectively communicate with other Product Delivery team members (Packaging, Quality, Supply Planning, Labelling, etc.)
• Language Requirements: Must be Fluent in English (both written and spoken).
• Additional Information/Requirements:

• Work outside of core hours may be required to support the portfolio across the globe.
• Roles posted in Cork may be requested to work flexible hours.
• May require travel domestically and international (less than 5%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLilly

Expected salary

Location

Cork

Job date

Sat, 19 Oct 2024 22:05:38 GMT

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