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Location

Carlsbad, CA | United States

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Job description

Job Description

If you are a 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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

The Associate Director, Clinical Outsourcing will facilitate the FSP, clinical trial outsourcing, vendor selection and contract negotiation, and reporting process for Jazz Pharmaceuticals’ clinical development programs. The Associate Director, Clinical Outsourcing will oversee the outsourcing and contracts management process as assigned.  S/he must have a comprehensive understanding of all functions and regulations required to conduct international clinical trials.

Under the guidance of the Director, Clinical Outsourcing s/he is responsible for the accurate and timely execution of all assigned FSP and study related contracts. S/he will ensure an effective, cross-functional contract and relationship management process and recommend outsourcing strategies to meet Jazz goals and to ensure best value from our vendors. 

Essential Functions (FSP)

• Accountable for working directly with applicable GCDO functions to request FSP resources, monitor service delivery and track monthly spend against yearly projections.
• Provide quarterly reporting to GCDO Leadership to summarize spend YTD as it relates to overall yearly forecast.
• Champion the FSP strategy and regularly provide training on FSP best practices to GCDO staff and managers.
• Lead governance for key FSP relationships across GCDO
• Ensure timely and appropriate delivery and meeting of FSP KPIs.  Work closely with FSP to proactively address any outstanding issues or concerns related to KPI and Service delivery.
• Facilitate invoice review/approval across all GCDO functions ensuring rates are consistent with contractual terms and staff billing by function is accurate across all active Work Orders.
• Refine FSP processes and financial controls as necessary aligned with growing business needs of GCDO. 
• Perform yearly review of Survey feedback and work closely with FSP staff to implement mitigations fueled by lessons learned.
• Work collaboratively with GCDO leadership to establish strategy for enhancement of FSP locations, responsibilities, and reporting.

Essential Functions (General)

• Build cross-functional relationships and ensure sourcing processes are understood and followed within the functional teams.
• Provide guidance to team members in difficult contract negotiations.
• Partner with internal Jazz stakeholders to develop, deliver and maintain operational sourcing strategies and relationships.
• Work with vendors for resolution of escalated issues and questions based on established governance policies.
• Collaborate with cross-functional (Legal, Finance, FP&A, Clinical Operations, Data Management) departments in selection and management of clinical trial vendors.
• Negotiate, track, and analyze FSP and/or clinical vendor KPIs to measure health of business relationships.
• Develop and streamline department processes and train key stakeholders.
• Represent the department in cross-functional R&D projects and initiatives.
• Lead process improvement initiatives that impact the broader department
• Provide support and expertise in developing effective clinical contractual agreements, forecasts, and budgets.

• Integrate clinical development program acquisitions into Jazz financial and contracting process.

• Assist in the monthly accrual process and financial obligations for FSP and/or projects.
• Manage tracking tools (spreadsheets, databases, etc.)
• Manage/supervise employee(s) (preferred but not required)

Required Knowledge, Skills, and Abilities

• Proven experience with FSP team management inclusive of financial planning, resource forecasting, reporting lessons learned, and setting international and cost saving strategies by function.  
• Demonstrated knowledge of and experience executing the clinical outsourcing process utilizing appropriate tools and systems
• Excellent negotiation skills required.
• In-depth knowledge and understanding of the legal, regulatory, and compliance-related issues and requirements in clinical trials.
• Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
• Strong knowledge of clinical trial functions (i.e., clinical data management, clinical operations, field monitoring, medical writing etc.) and key responsibilities, activities, and processes
• Experience managing stakeholders at various levels internally and with external partners.
• Demonstrated proficiency in conflict resolution (i.e., issue escalation/management).
• Excellent written, verbal, and interpersonal communication/interaction skills
• Ability to prioritize and handle multiple tasks simultaneously in a fast-paced, dynamic environment.
• Must have experience managing FSPs, CROs, central laboratories, and other clinical study vendors.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness (preferred not required)

Required/Preferred Education and Licenses

• Bachelor’s degree with seven to ten years of experience in the pharmaceutical or biotechnology industry; seven to ten years in clinical outsourcing and one to three FSP category management experience 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 anticipated base pay range is $156,000-$204,750. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

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

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