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The Clinical Trial (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 moved from the packager all the way to the sites 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 Distribution Buyer Planner will supervise the DMC will is accountable for the movement of finished goods from the packaging plant to the hub(s) as well as 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 outsource 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 supervise the DMC will is accountable for the movement of finished goods from the packaging plant (CP) to the hubs(s). For CP to Hub movement, the DMC will receive a communication from the Molecule Planner with information on what P-reqs to convert into Stock Transfer Orders (STO). The DMC will convert Preq into STOs. The Packaging Material Coordinator (PMC) will create the Outbound Delivery (OBD), assign batches to the OBD, and process the OBD. The DMC will also be accountable for the movement of finished goods from the hub to hub and hub to depot. The Clinical Supply Coordinator (CSC) will communicate to the DMC which Preqs to convert into STOs. The DMC will convert the Preq into STOs. The DMC will create the Outbound Delivery, the CSC will assign batches to the OBD and the DMC will process the OBD.
The Distribution Buyer/Planner will be accountable for managing and overseeing all plants that they are assigned within a zone. 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 Distribution Material Coordinator (s).
Key Responsibilities:
o Must be knowledgeable on how to apply GMPs and GDPs 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.
Requirements:
o Word, advanced knowledge of EXCEL
o Inventory management software
o Material requirements planning/ERP software
Additional Information:
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