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    Senior Manager, Clinical Trials Supply Management - Mississauga, Canada - Jazz Pharmaceuticals

    Jazz Pharmaceuticals
    Jazz Pharmaceuticals Mississauga, Canada

    3 weeks ago

    Default job background
    Full time
    Description

    Senior Manager, Clinical Trial Supply Management

    Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

    We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

    Position Profile

    The Senior Manager, Clinical Trial Supply Management will work as a member of the Jazz Pharmaceuticals' team, assisting in the development of new products and product line extensions by managing investigational products in support of the clinical development pipeline and other clinical and non-clinical studies. The core responsibilities include on-time delivery of study drug to patients/subjects and management of the clinical supply chain (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM). Key interactions are with Clinical Operations, Clinical Development, Pharmaceutical Development, Quality, and Regulatory, and with external vendors (packaging, IRT).The position reports to the Senior Director, Clinical Trial Supply Management.

    Essential Functions

  • Ensure on time delivery of clinical supply to depots and sites in accordance with each clinical protocol and plan
  • Work with cross-functional team to define clinical supply plan for each study; participate in relevant team meetings providing clinical supply status reports and support
  • Review clinical protocols for study supply requirements
  • Create label text in compliance with regulations, and manage translations and country –specific requirements.
  • Contribute to the design of study drug packaging in accordance with needs of the study
  • Manage vendors to perform the labeling, packaging, and distribution (global) of investigational product
  • Assist the development of IRT (IXRS) supply and return strategy, and participate in User Acceptance Testing where needed
  • Develop requirements/specifications for clinical study drug and other drug supply as required (GLP, non-GLP non-clinical), including packaged product specifications, product shipping and storage specifications
  • Contribute to study specific pharmacy manuals and supply related training/instructional materials (. IM and SIV slides, dosing cards, accountability forms)
  • Coordinate with Supply Chain for use of commercial products in a clinical environment
  • Stay current on all Jazz SOP's related to CTM/IMP distribution and follow procedures for release of IMP to clinical site(s)
  • Contribute to CTSM budget and forecasting; track invoices to contracts
  • Provide to Regulatory Affairs any applicable information or sections of IND/IMPD/CTA/etc. submissions
  • Knowledge and experience managing controlled drugs a plus.

    • Minimum Requirements

  • Bachelors Degree and a six to eight years professional experience, or equivalent experience, in pharmaceutical/biotech industry.
  • Experience in clinical trial supplies required; supply chain/distribution logistics/import export/customs experience a plus
  • Knowledge of regulatory requirements for IMP.
  • External vendor management experience required
  • Excellent written and oral communication skills.
  • Ability to work independently with minimal oversight
  • Strong interpersonal skills and ability to function in a dynamic team environment.
  • Strong computer skills, with proficiency in spreadsheet, presentation and word processing software.
  • Flexibility to travel on company business as required

    • FOR US-BASED CANDIDATES ONLY

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