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Responsible for Demand & Supply planning from Primary Packs to Drug product and Drug Substance for assigned projects. Owns and drives Clinical Demand Planning Meeting. Owns and drives DSM agenda aRD Sub- team to ensure demand fulfillment (supply and regulatory aspects). Provide transparency on supply constraints over time and manage related aspects accordingly within TRD via TRD Sub- teams and CS&OP; process. Is a key contributor of the CS&OP; (Clinical Supply and Operations Planning) process in TRD and of the SCM Forum.
1. Represents DSM in TRD sub- team, driving DS/ DP supply process in TRD, ensuring Drug Substance, Drug Product and Clinical Finished Good supply milestones are met. 2. Creates and manages DS/ DP supply plan on global project level, reviews supply plan in TRD sub- team and ensures agreements with BDSS/ CHAD/ PHAD/ BPRD on DS/ DP delivery quantity/ timeline. 3. Ensures most cost efficient material flow, minimizing waste and allowing the flexibility to accommodate changing demand. 4. Monitors project inventory level and drives decision on write- off/ extension. 5. Chairs Clinical Demand Planning Meetings and coordinates delivery of DS, DP, PP and CFG according to plan. 6. Liaises with TRD sourcing to define available options for comparators based on Clinical demand, country specific regulatory requirements and triggers technical feasibility testing. Outcome is base for procuring selected comparator 7. Plans budget for associated external costs for comparators and commercial drug products and issues related grants and purchase orders. 8. Coordinates and maintains the DSM project budget (planned and actual costs). 9. Consolidates changing demand data on project level in alignment with the DSM Trial Manager Supports internal/ external inspections and audits. 10. Proficient in SAP knowledge for relevant fields and excellence in operational use of SAP.
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