Associate / Sr. Associate - Externally Sponsored Research and Access Programs Drug Supply Coordinator
5 months ago
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 41,000 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 1,600 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:
In addition to Lilly-sponsored research, Lilly provides support for Externally Sponsored Research (ESR) and Access programs with provision of study drug and/or financial support.
Investigator Initiated Research (IIR) is initiated, designed, and sponsored by external researchers. Lilly considers such requests for support of Investigator Initiated Research (IIR) projects based on scientific merit and strategic fit with Lilly’s areas of research interest. Expanded access is the provision of an investigational medicinal product (IMP) for treatment of patients with a serious or life-threatening condition who are unable or do not qualify to participate in a clinical trial and for whom no satisfactory alternative therapy is available. Expanded access is not conducted for the purpose of answering research questions. Expanded access is known by other terms in different countries, such as compassionate use, emergency use, authorization for temporary use, individual patient investigational new drug (IND), named patient use (NPU), and named patient access program. Externally Sponsored Collaborative Research (ESCR) may be initiated by the Sponsor or may be a collaborative effort to explore a research objective.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 I nvestigator 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 experienceOther 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) Ability to use and apply multiple computer applications Knowledge of clinical trial packaging 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 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 Cork and/or Belgium may be requested to work flexible hours.May require travel domestically and international (less than 5%)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.
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