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.

The Senior Director (SD) and Head of Global Risk Management is responsible for providing leadership and strategy in the development, implementation, and maintenance of all Risk minimization activities for Jazz Pharmaceuticals products globally, including the US REMS activities.

The SD works with a team to deliver the strategic and operational components of risk minimization, working closely with Regulatory Affairs, Pharmacovigilance, Global Molecule team, Information technology, Channel Operations, local Markets, and other groups within Jazz, as well as with external vendors, to deliver compliant programs for JP marketed products.

The SD works effectively in matrix teams, to assure the effective delivery of programs under their accountability

Essential Functions

• Provides strategy and direction for cross-functional product REMS teams in the development, management, and monitoring of the operational activities required to support REMS, including Elements to Assure Safe Use
• Design, coordinate cross-functional processes to ensure a continuous improvement framework that facilitates appropriate changes and required submissions to FDA for REMS programs and to Health Canada for risk minimization activities
• Serves leadership role in the proactive management critical REMS-related issues
• Lead the development and maintenance of REMS procedures and documentation as well as risk minimization activities in Canada (in alignment with Canadian Market JP staff)
• Facilitate organization-wide understanding of REMS programs and develop required capabilities through communication and training
• Engage with Regulatory Authorities to optimize JP delivery of REMS and Global RMP related deliverables
• Maintain expertise in the regulatory environment, regulations, and requirements for Global Risk Management and REMS activities.
• Build partnerships with key stakeholders throughout the organization to ensure successful development, implementation, and maintenance of risk minimization programs
• Oversight of services, vendors, and budget to support the REMS,
• Works closely with local markets on services and vendors required

Required Knowledge, Skills, and Abilities

• Significant experience in pharmaceutical REMS program development and implementation
• Significant experience in risk minimization activities
• Track record of success in delivering project outputs via cross-functional teams and/or in a matrixed environment
• Knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and relevant Food and Drug (FDA) and international regulations and guidelines
• Track record of success in implementing project management principles, including planning and budgeting
• Strong computer skills and experience in data analysis and report preparation for FDA submission
• Knowledge of quality management principles and approaches (e.g., ISO 9001 QMS)
• Excellent verbal and written communication and influencing skills

Required/Preferred Education and Licenses

• Bachelor’s degree in relevant field required; Advanced degree preferred; minimum of 8 years in pharmaceutical industry with direct experience in PV, Safety or Risk Management related activities in the biopharmaceutical Industry required
• Experience with REMS programs required
• Requires history of being a practicing healthcare provider for a minimum of 4 years; by US Federal regulations, this includes: physicians, dentists, clinical psychologists, nurses and/or clinical social workers