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.

Associate, Externally Sponsored Research and Access Programs Drug Supply

Coordinator

Company Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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 Investigator Initiated Research (IIR), Expanded Access Programs (EAP), and other ESR 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 partiesWorking knowledge of GMP/GDP/GCP regulations.Minimum 1-year previous GMP supply chain experience

Other Information/Additional Preferences:

Knowledge of Import/Export compliance as it related to clinical trials and shipping medicinal productsPrior experience in ERP systemPrior experience with SAP is preferredPrior experience with GMP supply chains (wholesaler, manufacturer, CMO)Ability to use and apply multiple computer applicationsKnowledge of clinical trial packagingDemonstrated strong and effective written and verbal communication skills in multi-cultural and cross functional settingsDemonstrated exemplary teamwork/interpersonal skillsPrevious cross functional experiencesAbility to manage multiple tasks and respond quickly to changeAbility 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 detailsAbility to proactively identify problems and work toward a solutionLanguage 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 and/or Belgium 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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $155,100

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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