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Associate / Senior Associate - Clinical Trial Packaging Material Coordinator - Finished Goods (FING)
4 weeks ago
Position Title:Associate, Clinical Trial Packaging Material Coordinator- Finished Goods (FING)
About Lilly
Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Organization Overview: As a member of the Global Clinical Trial (CT) Supply 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.
Responsibilities:
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.
Lillydoes 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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