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Clinical Supplies Planner level 1
Ref No.: 18-12478
Location: Kenilworth, New Jersey
Start Date / End Date: 09/25/2018 to 09/25/2019

Clinical Supplies Planner (Level 1-3)

Summary: Serve as a member of client's clinical study team and/or clinical drug supply team to manage clinical supply planning and forecasting for study protocols. Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy. Support planning for global clinical supplies, including, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline. Manage drug supply delivery timelines with Clinical stakeholders, packaging source area(s), and indirectly with GMP laboratories, Quality Assurance, and Regulatory Affairs, as required. Communicate packaging progress, status updates, mitigation plans, and escalation of issues for clinical supply deliverables to ensure clinical supply timelines and deliverables are met for protocols.

Selected Responsibilities:

· Coordinate the origination, proofing and translation of clinical study labels, as required
· Support design and set-up of IVRS system
· Prepare required documentation and assist internal and external stakeholders to facilitate activities for the import and export of clinical supplies, as required.
· Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
· Monitor global clinical supply inventory for both IVRS and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
· Resolve issues involving distribution of clinical supplies, including US & International shipments, temperature excursions, etc.
· Manage clinical supply complaints received from investigative sites and/or subsidiaries, address supply replacement requests.
· Monitor expiry dating for clinical study supplies.
· Interact with other departments, as needed, to resolve any issues involving clinical supply inventory and distribution.

Education and Work Experience Requirements:

· A Bachelor's degree in health sciences or related field preferred
· Prior experience translating demand and supply planning into SAP preferred.
· Level 1 : 2 - 4 years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
· Level 2 : 4 - 6 years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
· Level 3 : 5 - 7 years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred