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Sr. Drug Supply Manager

Wayne Metro Area, NJ

Post Date: 09/21/2017 Job ID: JN -092017-20059
Description:
Plans, establishes, manages, monitors and performs activities related to preparation and distribution of supplies for US local Phase 4c studies, working with clinical team and approved vendors, in compliance with internal procedures and GxP requirements.
Leads the planning, creation, distribution and maintenance of clinical supplies for US Phase 4c studies (and local IITs).
Coordinates randomization, packaging, labeling and distribution of clinical supplies with clinical team and approved vendors as per the approved study design.
Accountable for creating eCPRs with good quality, ensures that key study milestones are met.
Establishes the packaging design based on protocol
Manages all packaging activities including Work Order creation, review and approval of contractor packaging records and monitoring work at contractors
Responsible for materials and inventory management of supplies for US local Oncology studies.
Timely communicates and updates clinical supply plan on study level to SCMs, ensure seamless coordination on demand/supply plan.
Authorizes destruction of outdated material
Manages all finance activities with clinical team including Request for proposal for bidding and vendor selection, purchase orders and invoice approval
Supports internal/external inspections and audits.
Creates reviews and updates the demand plans based on strategic elements/study forecasts.
Contributes to specifications with support for IVRS set up
Supports clinical team with medication management for IVRS studies
Reviews clinical trial protocol and provides input to drug sections. Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage.
Triggers label design process, leads packaging design and optimization, coordinates the randomization and distribution of clinical supplies according to study design.
Coaches other team members on specific topics (e.g. packaging design, finance etc.)
Establishes contact network with approved contractors and vendors
Primary liaison with contractors for external packaging and distribution campaigns
Establishes and manages supply related timelines with other groups as DSM, QA, and PHAD, to ensure agreed timelines are met
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Skills:
Excellent communication skills
Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience
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Education:
BA/BS

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