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Position Title: Associate, Clinical Trial Packaging Material Coordinator- Finished Goods (FING)

Each Associate level 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.

• Understand packaging configurations
• Understand packaging and labeling strategy
• Understand recipes for CT orders
• Understand unique packaging/delivery risks for assigned wor

Required Education or Certifications: Bachelor Science in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering, or related field, OR HS Diploma/GED with 5+ years’ experience in clinical.

• No other certifications are required; however, Project Management Professional (PMP) or other project management certification can set candidate apart from others.
• Experience in managing inventory/supplies or complex supply chains as well as basic knowledge of clinical trial packaging, is also a differentiator between candidates

Portfolio Assignments

Each Associate level 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.

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

Judgement and Critical Thinking

This role requires the PMC 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. The PMC builds 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
• Use Detailed Collaboration Partner Requirements (DCPR) to understand CT order compliance
• Issue documents required to describe order to packager (e.g., MCR, label random table, MSDS, etc.)
• Forward process CT Orders timely by completing SAP transactions including quotes/RFP, eBuy carts, step closures and Goods Receipt.
• Complete electronic documents timely (e.g., Pre/Post batch record tools, Quality database)
• Ship to HUB: Issue CP documentation required for shipment, issue STO/OBD, and confirm ASN is available upon arrival at first HUB
• Raise a concern if there is a delay or issue

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)

Finance

PMCs 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.

• Approve quotes
• Request Procurement approval of quotes >$500K
• Minimize PO blocks
• Ensures compliance to the FRAP policy

Unique Opportunities
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.
This is the project side of the role. PMCs can grow various specialty areas to help with next steps or general fulfillment in contributions
Minimum Qualifications: Bachelor Science in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering, or related field, OR HS Diploma/GED with 5+ years’ experience in clinical.

Required Education or Certifications: Bachelor Science in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering, or related field, OR HS Diploma/GED with 5+ years’ experience in clinical.

• No other certifications are required; however, Project Management Professional (PMP) or other project management certification can set candidate apart from others.
• Experience in managing inventory/supplies or complex supply chains as well as basic knowledge of clinical trial packaging, is also a differentiator between candidates.

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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