Sr 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. Under the direction of the Associate Director, the Senior Manager, Strategic Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, management, and reporting process for Jazz Pharmaceuticals'' clinical development programs.Job Responsibilities and Requirements:Partners with internal Jazz stakeholders to develop, deliver and maintain clinical outsourcing strategies and relationships.Works with vendors for to proactively manage risk, resolve issues and address questionsCollaborates with cross-functional (Legal, Finance, FP&A, Clinical Operations, Data Management) departments on activities relating to vendors and business partnersLeads the evaluation, selection and negotiation and contracting process with vendors and sites in conjunction with functional teamsGenerates RFPs, RFIs and contract templates in support of the clinical outsourcing processCreates and provides budget forecasts and cost-modeling for clinical trials, as neededOversees the development and negotiation of CDAs, clinical site budgets and clinical trial agreements with investigative sitesLeads and manages the negotiation of clinical development contracts, including MSAs and work orders for CROs and other clinical category vendors such as eCOA, IRT and central laboratories.Represents Strategic Outsourcing to cross-functional teams, providing training on outsourcing and contracts process as requiredTakes a leadership role in coaching R&D on current processes and policies as it relates to Clinical OutsourcingUtilizes insight from data analytics and tracking tools to support vendor performance management and cost-savings initiativesMay lead or roll out departmental initiatives/projects in support of Jazz R&D.May lead or support vendor governance activities, as requiredMay manage/supervise and contribute to the training and professional development of staffEssential Requirements: Bachelor''s degree with minimum five years of clinical outsourcing experienceExcellent verbal, written and interpersonal communication skills in a dynamic and growing organizationMust have a comprehensive understanding of the drug development processWorking knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safetyExtensive experience collaborating cross-functionally to develop RFPs, RFIs, and study budget/contract templatesProven track record negotiating contracts and budgets with international vendors and clinical sitesMust have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sitesUnderstanding of international clinical pharmaceutical standards, ICH/GCP guidelines and compliance and legal issues related to the conduct of clinical trialsStrong time and project management skills with the ability to prioritize and handle multiple tasks simultaneouslyJazz 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