Pharmaceutical Planning Coordinator
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POST DATE 8/26/2016
END DATE 12/19/2016
Veterans Sourcing Group
JOB DESCRIPTION_Our Client in the Pharmaceutical industry is seeking a Planning Coordinator to join their team on a long term temporary basis at their Princeton, NJ location._
KEY RESPONSIBILITIES AND MAJOR DUTIES
* Works cross-functionally as part of a dynamic matrix team to plan delivery of clinical drug supply
* Provides projections to the Drug Supply Manager based on the protocol and planned 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 on-going 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.
* Monitors clinical trial activity and the usage of drug supply at sites and warehouses.
* Advises DSM of drug supply constraints and recommends alternative strategies to influence the ability of CSO to meet existing or anticipated demands.
* 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.
* 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.
* 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.
* 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).
* 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.