- Expiry Date: 17 January 2022
Duration-6+months (high possibility of extension)
Global Clinical Supply Chain (CSC) is a new organization within Global Supply Chain (GSC). GSC’s vision is to be a patient-centric, integrated supply chain, launching and supplying innovative products that deliver hope to patients through life-changing medicines. The Global Clinical Supply Chain (CSC) organization contributes to this vision by working seamlessly across the enterprise to supply global portfolio of clinical studies. CSC represents an innovative organizational model, an innovation that enables for a future in which commercial supply chains will be increasingly similar to clinical supply chains due to advances in personalized medicine and targeted therapies.
Provide streamlined inventory planning for R&D clinical supply chain activities including product based and/or program level supply planning, in order to deliver drug supply to depots and sites in preparation for patient treatment for assigned studies across the R&D Portfolio.
Roles and 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 program level assumptions by reviewing the study design, dosing schedule, and high-level assumptions through discussions with the Trial Supply Manager (TSM). Creates a Study Planning document for new studies, where applicable.
For program level supply planning, provides study level projections to the TSM 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.
For product level supply planning, the Trial Supply Manager (TSM) provides the depot planning template, which contains product specific demand required for the established time period. The Senior Specialist utilizes this information to plan depot shipments and ensure sufficient supplies are at the local depots.
Inventory planning for product and program level management includes responsibility for monitoring expiry dates and ensuring replacement supply is available at the local depots and communicating upcoming inventory concerns to responsible TSM.
Responsible for allocation of study drug in the appropriate IRT systems for IRT based studies. Uses FIN allocation tracker, as applicable, to keep track of allocations of supplies in IRT systems as well as for manual allocations.
Ensures country/study approval of product for assigned programs/studies as part of depot planning.
Provide manual allocations to TSM’s as requested (e.g. generic labeling form [GLF], investigator sponsored research [ISR] studies).
Develops and maintains Drug Provision Plans (DPP), for material movements between warehouses and manual drug order allocations, for assigned projects based on study or product level projections and communicates these plans to the Shipment Execution Team.
Monitors clinical trial activity and the utilization of drug supply vs. forecast 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. Communicates changes to the Shipment Execution Team. Advises TSM of drug supply constraints and recommends alternative strategies to influence the ability of CSC to meet existing or anticipated demands.
Track shipments through MRB date and communicate issues/delays as needed.
Utilizes the Use Date Extension Memo SharePoint to upload UDE’s. Provides a notice of use date extension to key stakeholders where required.
If applicable, for program level supplies, 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 chain processes.
Performs other tasks as assigned.
Skills and Qualifications
Supply chain or Pharma industry related experience is a plus
Moderate knowledge of the global drug development process and global regulatory requirements with respect to investigational new drugs.
Proficient analytical and negotiation skills.
Proficient project management skills and handling multiple projects simultaneously.
Proficient knowledge of Forecasting and Planning, Inventory management and Supply Chain Functionality
Proficient knowledge of import / export requirements.
Proficient knowledge of industry technology.
Strong oral and written communication skills (fosters open communication).
Proficient teamwork and collaboration skills.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrit bring out the highest potential of each of our colleagues.
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