Manager, Strategic Outsourcing

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 and follow @JazzPharma on Twitter. The Manager, Strategic Outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals'' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Strategic Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Jazz'' clinical studies..Job Responsibilities and Requirements:Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts processGenerate RFIs, RFPs, and contract templatesAssist Clinical Trial Managers with quarterly internal budget forecasts of clinical projectsAssist Associate Director with costing trials for internal planning purposesNegotiate and maintain clinical development contracts, including vendor and site CDAs, MSAs, clinical site agreements, investigator meeting agreements, Work Orders for external clinical service providers, consultant agreements and specialty vendor contractsOversee Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocolsOversee CRO/FSP activities in regard to site CDAs and clinical site agreementsSubmit purchase requisitions and manage contract approvals through the legal repository systemInterface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sitesManage selection process and develop strong relationships with vendors in conjunction with cross-functional teamsOrganize bid defense meetings as requiredDevelop and maintain tracking tools (spreadsheets, databases, etc.),Attend team meetings as appropriate, represent Strategic Outsourcing on cross-functional clinical trial working group meetings.Assist in the monthly accrual process and financial reporting for projectsAssist Associate Director with departmental process improvements as neededWork in collaboration with Compliance on FMV; Review Aggregate Spend Tracker for ComplianceMay help train individual contributor/professional employeesEssential Requirements: Bachelor''s degree with five years of clinical outsourcing experienceExcellent verbal, written and interpersonal communication skills in a dynamic and growing organizationExperience generating RFPs, RFIs, and study budget/contract templatesProven track record negotiating contracts and budgets with both U.S. and international vendors and global clinical sitesIn-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred.Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plusUnderstanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issuesWorking knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safetyAbility to prioritize and handle multiple tasks simultaneouslyMaintain up to date information on changing healthcare regulations affecting clinical trial paymentsJazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.Some limited travel may be requiredJazz 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.

Created: 2021-11-29