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.

As a member of the Global Clinical Trial (CT) Packaging team, you could support the portfolio for any Phase 1, 2, or 3 clinical trials. To get our work done, we collaborate with packaging CMOs; we learn how to navigate the dynamic CT space we develop knowledge about packaging and labeling operations; we problem solve; we work closely with other functions to innovate, gain efficiency to accelerate, and build strong relationships to maintain and sustain our mission.

Each Finished Goods (FING) packaging material coordinator (PMC) is assigned pipeline compounds within Lilly’s portfolio to support the packaged clinical trial materials that are dispensed to patients in the studies.
This is our critical business, and knowledge of packaging engineering, package forms, labeling, drug products and project management skills are highly valued.

We expect you to understand:

- packaging configurations
- packaging and labeling strategy
- recipes for CT orders
- unique packaging/delivery risks for assigned work

This role requires to build relationships across several groups throughout Product Delivery and external partners. To do this it is important to know the key partners for help, advisement, and escalation. You will build strong partnerships with:
• FING Plant Planners, who own the packager relationships and strategically
manage the forecast for PD.
• CT Supply Planning Molecule Planners and Supply Managers, who work together to develop the plan for each clinical trial
• Packaging and Distribution Quality, who are responsible for releasing the CT
material that is made at the packagers

Documentation is a key part of the role. Elements of this include:
• Accessing, creating and providing documentation for the packager
• Reviewing and understanding batch records as well as collaborating with Lilly
quality and external packaging partners to manage details and timeline of all assigned CT orders.
• Anticipating, raising awareness and solving issues that arise relative to the
assigned CT orders.

Proficient or high learning agility to become proficient in systems used to execute work.
These systems include:
• SAP (enterprise resource planning) for order management and financial transactions
• Electronic document control system (e.g., Regulus, Quality Docs/Veeva
Vault)
• SharePoint Online
• Trackwise (deviations and change management)

You are responsible for approving quotes (up to $500K) for the CT packaging work completed at the packagers. This requires understanding the pricing agreements, executing transactions in SAP, and monitoring invoices to ensure they match quotes and CPs can be paid for the work completed.

This role also allows for building expertise in different areas like Trackwise investigation, qualification of new capabilities at our packagers, process improvement projects, metrics, leading a change, etc.

Qualifications

Bachelor Science in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering, or related field.

5+ years’ experience in clinical trials.
Previous project management experience is an asset.
Experience in managing inventory/supplies or complex supply chains as well as basic knowledge of clinical trial packaging, is also a differentiator between candidates.

Strong communication skills in English and French.

You can work virtually and you are flexible.

Problem solver and and team player

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 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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