Senior Manager, Clinical Trials Supply Management - Lifelancer

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

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 (e.g. 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
  
  

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $132,000.00 - $198,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.