Katalyst Healthcares & Life Sciences
Drug Planning Coordinator
Katalyst Healthcares & Life Sciences, Princeton, New Jersey, us, 08543
Job Description
Purpose/Objective of the job:Provide streamlined warehouse planning for clinical supply chain activities in order to deliver drug supply to warehouse depots and sites in time for patient treatment for assigned studies in the R&D Portfolio. Develops study planning documents, as well as study level projections and continuously monitors and re-forecasts projections based on actual study progress through study completion. Develops and adjusts the Drug Provision Plan to ensure delivery of sufficient supply to cover demand to warehouse depots and ensure availability of allocation for manual (non-IRT) studies. Communicates to key stakeholders regarding adherence to project strategy and timelines.Responsibilities :Works cross-functionally as part of a dynamic matrix team to plan delivery of clinical drug supply to ensure sufficient supply availability for new and ongoing studies.Understands study level assumptions by reviewing the study design, dosing schedule, and high level assumptions through discussions with the Drug Supply Manager (DSM). Creates a Study Planning document for new studies.Provides study level projections to the DSM based on the protocol and planned countries/sites/patients/enrollment duration/shipping lead times and recalculates monthly projections based on actual study progress from study enrollment through study completion.Provides revised real-time drug forecast for ongoing studies to the DSM on a monthly basis. Recommends changes to the Program Supply Plan for ongoing studies based on current inventory levels, to prioritize manufacturing and purchasing decisions for seamless resupply for ongoing studies. Attends Long Range Operations Planning (LROP) Team meetings to stay informed of upcoming releases and provides feedback regarding adjustments to the Program supply plan as needed.Develops drug provision plans (which includes material movements between warehouses, and manual drug order allotments) for assigned projects based on study level projections and communicates these plans to the Shipment Execution Team. Ensures distribution requirements are planned and communicated to the Shipment Execution Team Lead (SETL) via the Drug Provision Plan at least 6 months in advance.Monitors clinical trial activity and the usage of drug supply at sites and warehouses. Makes necessary changes to the Drug Provision Plans based on various study factors (recruitment/timing/etc.) to enable timely resupply of IMP. Advises DSM of drug supply constraints and recommends alternative strategies to influence the ability of CSO to meet existing or anticipated demands.Participates in the development of user requirements specifications for Interactive Response Technology (IRT) related to drug supply algorithms and other drug related information.Allocates clinical supplies within IRT and proactively manages incremental IRT parameter changes when needed to ensure drug supply algorithm is working optimally through all phases of the study.Collaborates with the Shipment Execution Coordinators (SEC) and key customers to determine the need for field transfer of investigational product.Provides a notice of use date extension to key stakeholders where required.Prepares Product Information Listings and batch listing extract files as required for study database locks and regulatory filings.Participates on key task forces for improvement initiatives and procedural updates. Recommends and implements ways to improve the efficiency of clinical supply processes.Acts as interface to key customers for information, training and resolution of issues as it pertains to drug planning and IRT.(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)Requirements:Bachelor's degree in Business or Pharmaceutical Sciences, or related science or equivalent relevant work experience.Knowledge of pharmaceutical science normally attained through the achievement of a Bachelor's degree and a minimum of 2-4 years' experience in clinical supply planning and coordination within the pharmaceutical industry.Management of clinical drug supply warehouse planning and worldwide distribution according to defined timelines.Participation as a department representative in a culturally diverse project team which deals with a complex, changing environment while managing time bound project goals.Proficient in supply forecasting/planning/allocation and IRT management.Knowledge of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.Mastery of the global clinical supply process and its role in the achievement of clinical research goals.Strong communication skills and customer service orientation.Has a high level of problem solving skills and uses them to monitor key milestones in the global clinical supply process.Personal experience in achieving goals and objectives through effective collaboration of staff and resources not under your direct control.
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Purpose/Objective of the job:Provide streamlined warehouse planning for clinical supply chain activities in order to deliver drug supply to warehouse depots and sites in time for patient treatment for assigned studies in the R&D Portfolio. Develops study planning documents, as well as study level projections and continuously monitors and re-forecasts projections based on actual study progress through study completion. Develops and adjusts the Drug Provision Plan to ensure delivery of sufficient supply to cover demand to warehouse depots and ensure availability of allocation for manual (non-IRT) studies. Communicates to key stakeholders regarding adherence to project strategy and timelines.Responsibilities :Works cross-functionally as part of a dynamic matrix team to plan delivery of clinical drug supply to ensure sufficient supply availability for new and ongoing studies.Understands study level assumptions by reviewing the study design, dosing schedule, and high level assumptions through discussions with the Drug Supply Manager (DSM). Creates a Study Planning document for new studies.Provides study level projections to the DSM based on the protocol and planned countries/sites/patients/enrollment duration/shipping lead times and recalculates monthly projections based on actual study progress from study enrollment through study completion.Provides revised real-time drug forecast for ongoing studies to the DSM on a monthly basis. Recommends changes to the Program Supply Plan for ongoing studies based on current inventory levels, to prioritize manufacturing and purchasing decisions for seamless resupply for ongoing studies. Attends Long Range Operations Planning (LROP) Team meetings to stay informed of upcoming releases and provides feedback regarding adjustments to the Program supply plan as needed.Develops drug provision plans (which includes material movements between warehouses, and manual drug order allotments) for assigned projects based on study level projections and communicates these plans to the Shipment Execution Team. Ensures distribution requirements are planned and communicated to the Shipment Execution Team Lead (SETL) via the Drug Provision Plan at least 6 months in advance.Monitors clinical trial activity and the usage of drug supply at sites and warehouses. Makes necessary changes to the Drug Provision Plans based on various study factors (recruitment/timing/etc.) to enable timely resupply of IMP. Advises DSM of drug supply constraints and recommends alternative strategies to influence the ability of CSO to meet existing or anticipated demands.Participates in the development of user requirements specifications for Interactive Response Technology (IRT) related to drug supply algorithms and other drug related information.Allocates clinical supplies within IRT and proactively manages incremental IRT parameter changes when needed to ensure drug supply algorithm is working optimally through all phases of the study.Collaborates with the Shipment Execution Coordinators (SEC) and key customers to determine the need for field transfer of investigational product.Provides a notice of use date extension to key stakeholders where required.Prepares Product Information Listings and batch listing extract files as required for study database locks and regulatory filings.Participates on key task forces for improvement initiatives and procedural updates. Recommends and implements ways to improve the efficiency of clinical supply processes.Acts as interface to key customers for information, training and resolution of issues as it pertains to drug planning and IRT.(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)Requirements:Bachelor's degree in Business or Pharmaceutical Sciences, or related science or equivalent relevant work experience.Knowledge of pharmaceutical science normally attained through the achievement of a Bachelor's degree and a minimum of 2-4 years' experience in clinical supply planning and coordination within the pharmaceutical industry.Management of clinical drug supply warehouse planning and worldwide distribution according to defined timelines.Participation as a department representative in a culturally diverse project team which deals with a complex, changing environment while managing time bound project goals.Proficient in supply forecasting/planning/allocation and IRT management.Knowledge of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug shipment regulations.Mastery of the global clinical supply process and its role in the achievement of clinical research goals.Strong communication skills and customer service orientation.Has a high level of problem solving skills and uses them to monitor key milestones in the global clinical supply process.Personal experience in achieving goals and objectives through effective collaboration of staff and resources not under your direct control.
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