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.
The CT Supply Planning Organization is accountable for the development of molecule/study demand forecasts in partnership with the clinical team and the subsequent implementation of the supply plans. Additionally, the Supply Planning organization is accountable for the timely supply of New Drug Product and Finished Goods to internal and external partners. This will be accomplished by planning and scheduling via an MRP system (SAP). CT Distribution has the responsibility to ensure that CT materials are delivered from suppliers and moved all the way to the sites/hubs/depots in a FFU condition and on-time.
In order for this to happen you must have a global network of qualified hubs and depots with good processes, quality oversight, solid management and oversight, continuous improvements, sustainable cost structure and responsive to environmental changes. Additionally, you must have people managing the large number of transactions that are flowing through the systems and ensuring flawless daily execution.
Distribution will have two groups of staff for each zone that will manage these different variable and fixed components. The Distribution Buyer/Planner(s) and the Distribution Material Coordinator(s) will work together to manage the daily transaction piece (variable work) and the exception management processes that flow from more than 1200 annual bulk shipment orders and 60,000 to 80,000 site shipment orders. The Distribution Buyer Planner in cooperation with the Distribution Material Coordinator (DMC) will manage the infrastructure (fixed components) of the operations to ensure that the transactions can occur flawlessly each day. The DMC will be accountable for the movement of finished goods as from reception from the packaging plant to the hub(s) and for hub to hub and hub to depot movement. The DMC will also be responsible for general oversight of all material movement to sites from Hubs and Depots. Our Collaboration Partners generally manage this well but exceptions occur regularly requiring immediate intervention and decision making that have patient and CT material implications. In addition, they will be required to lead or participate in special projects supporting the development and implementation of distribution strategies related to products and capacities. The Distribution Buyer/Planner will be accountable for managing and overseeing all plants that they are assigned. They will also have responsibility to work with the other buyer/planners to ensure harmonization within and between zones and plants across the globe. They will be responsible for all activities for their plants including: strategy, staff, budgets, communications, Hub and Depot networks, processes in and between zones, relationship with vendors and overall quality.
The Distribution Buyer / Planners have a staff of Distribution Material Coordinator (s).

Key Responsibilities:

• Partners with the FING Distribution Plant Buyer/Planners and CTSM to understand delivery schedule and priorities; partners with quality, Clinical and hub/depot for delivery execution activities
• Monitors CT-WIN and/or SAP deliveries due list for all shipments
• Resolves issues with hub/depot and manages deviation investigations related to all shipments as needed
• Approves Quality Notification Forms from CPs
• Create ICI when needed
• Accountable for shipping documentation availability with hub/depot; Ensure completion of any pre-shipment paperwork and ensures necessary import approvals are in place prior to shipment execution
• Ensures execution of the delivery in-time to meet the demands at the receiving plant
• FFU determinations in case of temperature excursion
• For non-CT-WIN depots, monitor the receipt of periodic delivery data; periodic inventory reconciliation
• Identify related errors between CT-WIN and SAP
• Understands LRL Financial policies as they relate to CT Material and/or Investigational Devices and commercial pricing
• Author deviations and change controls and perform investigations as necessary to address departures from SOPs
• GMP Compliance o Must be knowledgeable on how to apply GMPs in a clinical trial environment and review and follow procedures applicable to the CT business. In addition, individual training plans must be kept up to date.
• Ensure compliance with GDP/GMP of activities performed on behalf of Lilly knowledgeable on how to apply GMPs and GDPs in a clinical trial environment and follow procedures applicable to the CT business
• Ensure all internal and external regulatory requirements are met for Importation, warehousing, labelling and distribution activities for all type of products
• Participate or co-lead cross zone communication meetings
• Participate in the Metrics review meetings with the zone and distribution leadership
• Participate in the Metrics review meetings with couriers
• Participate in the creation and update of the C.T. Distribution processes, and the training to our clients
• Participate in S&OP (schedule and metrics) and monthly publishing of plans to stakeholders
• Monitor and ensure that messages are being sent and there are no system failures
• Proactively identifies ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk through the use of the Six Sigma methodology
• Creation and maintenance of the distribution networks (both on paper and in the system) and P-Info records
• Push Outbound Deliveries (OBD) from SAP to CT-WIN (as needed)
• Create Purchase Orders for distribution vendors
• Review and approve invoices received from distribution vendors
• Develop and obtain cutover calendars from Hubs/Depots (e.g. Xmas)
• Create process flows for new Country regulatory requirement and give training to all concerned parties
• Ensure material set-up in CT-WIN for material not packaged by Product Delivery (creation of items and lots)
• Participate to visits to Hubs/Depots and Affiliates as instructed by the C.T. Distribution Buyer/Planner
• Support conference calls/meetings with Hubs/Depots/Affiliates and generate minutes
• Participate in projects linked to distribution process changes, including participate in the associated change control
• Provide support to projects as needed
• Act as Power User for CT-WIN and/or SAP (if applicable)

Health, Safety and Environment: Carry out the activities in accordance with company and site safety and environmental requirements.

• Confidentiality: Ensure confidentiality of information

Educational Requirements:

• Bachelor degree, preferably in health care or supply chain/logistics field or equivalent work experience.

Experience Requirements:

• Min. 5 years of experience in Clinical Trial Distribution is required
• Experience in managing inventory/supplies or complex supply chains
• Demonstrated exemplary teamwork/interpersonal skills
• Strong organization and self-management skills
• Ability to use and apply multiple computer applications
• Ability to manage multiple tasks and respond to change
• Effective written and verbal communication skills in multi-cultural settings
• High initiative, flexible and positive attitude
• High degree of accuracy with work and attentive to details
• Ability to proactively identify problems and work toward a solution
• Understands global shipping requirements, including country-specific requirements

• Understands LRL financial policies as they relate to investigational product and commercial pricing • Demonstrated knowledge of cGMPs and experience in a highly regulated environment

• Must speak fluent English

Additional Preferences:

• Knowledge of global import/export requirements
• Clinical research/study expertise
• Prior experience with SAP

Additional Information/Requirements:

• Work outside of core hours may be required to support the portfolio across the globe
• Minimal travel may be required, both domestic and international

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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• Partners with the FING Distribution Plant Buyer/Planners and CTSM to understand delivery schedule and priorities; partners with quality, Clinical and hub/depot for delivery execution activities
• Monitors CT-WIN and/or SAP deliveries due list for all shipments
• Resolves issues with hub/depot and manages deviation investigations related to all shipments as needed
• Approves Quality Notification Forms from CPs
• Create ICI when needed
• Accountable for shipping documentation availability with hub/depot; Ensure completion of any pre-shipment paperwork and ensures necessary import approvals are in place prior to shipment execution
• Ensures execution of the delivery in-time to meet the demands at the receiving plant
• FFU determinations in case of temperature excursion
• For non-CT-WIN depots, monitor the receipt of periodic delivery data; periodic inventory reconciliation
• Identify related errors between CT-WIN and SAP
• Understands LRL Financial policies as they relate to CT Material and/or Investigational Devices and commercial pricing
• Author deviations and change controls and perform investigations as necessary to address departures from SOPs
• GMP Compliance o Must be knowledgeable on how to apply GMPs in a clinical trial environment and review and follow procedures applicable to the CT business. In addition, individual training plans must be kept up to date.
• Ensure compliance with GDP/GMP of activities performed on behalf of Lilly knowledgeable on how to apply GMPs and GDPs in a clinical trial environment and follow procedures applicable to the CT business
• Ensure all internal and external regulatory requirements are met for Importation, warehousing, labelling and distribution activities for all type of products
• Participate or co-lead cross zone communication meetings
• Participate in the Metrics review meetings with the zone and distribution leadership
• Participate in the Metrics review meetings with couriers
• Participate in the creation and update of the C.T. Distribution processes, and the training to our clients
• Participate in S&OP (schedule and metrics) and monthly publishing of plans to stakeholders
• Monitor and ensure that messages are being sent and there are no system failures
• Proactively identifies ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk through the use of the Six Sigma methodology
• Creation and maintenance of the distribution networks (both on paper and in the system) and P-Info records
• Push Outbound Deliveries (OBD) from SAP to CT-WIN (as needed)
• Create Purchase Orders for distribution vendors
• Review and approve invoices received from distribution vendors
• Develop and obtain cutover calendars from Hubs/Depots (e.g. Xmas)
• Create process flows for new Country regulatory requirement and give training to all concerned parties
• Ensure material set-up in CT-WIN for material not packaged by Product Delivery (creation of items and lots)
• Participate to visits to Hubs/Depots and Affiliates as instructed by the C.T. Distribution Buyer/Planner
• Support conference calls/meetings with Hubs/Depots/Affiliates and generate minutes
• Participate in projects linked to distribution process changes, including participate in the associated change control
• Provide support to projects as needed
• Act as Power User for CT-WIN and/or SAP (if applicable