Manager, Strategic Outsourcing
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4178
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
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.
The Manager, Strategic Outsourcing will manage the clinical trial outsourcing, vendor selection and contract negotiation process for Jazz Pharmaceuticals’ clinical development programs.
Job Responsibilities and Requirements:
The Manager, Strategic Outsourcing will manage the outsourcing and contracts management process for Jazz Pharmaceuticals’ clinical development programs. S/he must have an expert and comprehensive understanding of all functions and regulations required to conduct global clinical studies. Under the direction of the Senior Director, Strategic Outsourcing, s/he is responsible for the vendor selection, contract negotiation and maintenance, and financial management processes in support of Jazz’s clinical studies.
The Manager, Strategic Outsourcing will:
- Assist Senior Director in the management of the outsourcing, vendor selection and clinical contracts process
- Generate RFPs, RFIs and contract templates
- Assist Clinical Trial Managers with quarterly internal budget forecasts of clinical projects
- Assist Senior Manager with Portfolio Planning process annually
- Negotiate and maintain clinical development contracts, including CDAs, MSAs, clinical trial agreements, Investigator Meeting Letters, Work Orders for external clinical service providers, consultant agreements and specialty vendor contracts
- Develop clinical site budgets using online industry benchmarking tool and partner with clinical operations to ensure budgets are in line with study protocols
- Oversee CRO activities in regards to site CDA’s and site contracts
- Submit purchase requisitions and manage contract approvals through the legal repository system
- Interface with cross-functional teams, including legal, compliance and clinical operations functions in selection and management of vendors and study sites
- Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams
- Organize bid defense as required
- Develop tracking tools (spreadsheets, databases, etc.),
- Attend team meetings as appropriate, including on CTWG.
- Assist in the monthly accrual process and financial reporting for projects
- Work in collaboration with Compliance on FMV; Review Aggregate Spend Tracker for Compliance
- May manage/train individual contributor/professional employees, or supervisors of employees.
- Bachelor’s degree with five years of contract experience in the pharmaceutical or biotechnology industry
- Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
- Extensive experience generating RFPs, RFIs, and study budget/contract templates
- Proven track record negotiating contracts and budgets with both U.S. and international vendors and clinical sites
- In-depth knowledge of compliance and legal issues related to the conduct of clinical trials
- Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
- Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
- Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
- Ability to prioritize and handle multiple tasks simultaneously
- Maintain up to date information on changing healthcare regulations affecting clinical trial payments
- Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.
- Some limited travel may be required