Associate - Clinical Trial Packaging Material Coordinator - Finished Goods

24 hours ago


Cork, Ireland Eli Lilly and Company Full time

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 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. In-house 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

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.

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.

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.

Systems

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.

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.

Minimum Qualifications:

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

Additional Information:

- 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.

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