Reference #: 11476
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.
We are looking for enthusiastic talented individuals who thrive on challenge and change, and who want to make a difference through delivery of results.Brief Description:The Director, Global R&D Compliance & Ethics works under the limited direction of the Executive Director, Compliance and Ethics Officer, NA Commercial and Global R&D ("E.D. R&D") to manage critical compliance activities that are integral the development, implementation and execution of the Jazz Compliance and Ethics program, also known as I-CARE (Integrity, Compliance, Accountability, Respect and Ethics), to ensure corporate compliance with applicable legal requirements and industry codes of practice. This position provides Ethics and Compliance leadership across the Global R&D organization and requires strong working knowledge of applicable laws, regulations, and industry codes of conduct globally wherever Jazz conducts business. R&D at Jazz consists of clinical development, clinical operations, global medical affairs, as well as various pre-clinical and early research activities, which require tailored compliance and ethics program elements.This position will be the primary point of contact for R&D and will coordinate compliance support with other areas in the I-CARE team, as needed. This role provides technical leadership and will assist in setting the strategy and direction within I-CARE to enable the implementation of an effective compliance program in R&D and connecting to the various R&D sites. As part of this organizational responsibility, the Director is also responsible for developing and implementing operations necessary to ensure compliance requirements are met. This role coordinates with Quality, Legal and/or HR to support any Corrective/Preventative and Disciplinary Actions resulting from compliance failures. Regular networking with quality, audit, legal and regulatory as well as with compliance colleagues internally and externally is essential to ensure alignment with company policies and compliance objectives.Principal Duties and Responsibilities:
Deliver effective compliance business partnering, and solution-oriented compliance advice and risk mitigation on overall business strategies, decisions, and activities conducted within R&D and/or overseen by R&D
Ensure that I-CARE program elements are appropriately tailored to R&D activities and operations, enabling the business to meet business goals in an effective and compliant manner and foster agility and innovation
Influence leadership through effective communication of the external environment and internal policies/standards
Ensure key elements of an effective compliance program are built into local governance and decision forum, business and operational processes, and training and appropriately tailored to R&D activities
Lead I-CARE activities associated with R&D. Given next generation development, new/evolving R&D sites, innovation goals, new clinical trial strategies and an increasing range and scope of partnerships/collaborations, ensure reliable controls are i place and understood and consult with various programs/teams and other I-CARE team members as necessary
Analyze and identify program and business risks
Drive effective implementation of the I-CARE program through R&D
Support the E.D. R&D in creating and maintaining an R&D Compliance Committee
Accountable for follow up on monitoring and audit findings as appropriate
Ensure R&D Ethics and Compliance needs are reflected in the support plans of corporately based I-CARE groups (such as training, monitoring, etc.)
Ensure an open and collaborative environment that promotes teamwork, open communication, and collaborative interactions among team members and with the broader R&D site leads
Provide input into development of I-CARE Policies and Procedures that reflect the needs/remit of R&D
Ensure business processes and operational procedures are consistent with Global I-CARE Policies and Guidance
Provide compliance support as needed for investigations of non-compliant activities and appropriate corrective action/disciplinary steps
Leadership and Professional Skills
Business Partnership: Proactively fosters partnerships within R&D to drive win-win solutions; commits to decisions for the best interest of the company
Critical Thinking: Formulates clear, rational, and informed solutions and insights that drive better decisions
Training: Train R&D on compliance guidelines, policies, ethical conduct and best practices
Guidance: Provide regular guidance regarding the I-CARE Program
Reporting: Provide strategic insights based on compliance data analysis
Problem Solving: Draws from all available resources and uses logic to develop solutions to complex or difficult issues
Business Knowledge: Develop a comprehensive understanding of the products, initiatives and goals of the R&D organization
Excellence focused: Demonstrates discipline and commitment to turn strategy into reality; drives results by focusing on prioritization and continuous improvement
Inquisitive: Shows curiosity, asks probing questions and challenges the status quo to make strong decisions while managing and driving change
Optimistic: Has a positive outlook; aligns with business needs and has a can-do attitude
Influencer: Persuades others to follow a path; can negotiate to win
Adaptability: Demonstrates resilience and versatility when pivoting to meet changing business needs
Risk Management: Forecasts and evaluates risk to make insight-driven decisions; implements measures to mitigate unnecessary riskRequired Knowledge, Skills, and Abilities
Previous healthcare compliance experience with pharmaceutical/biopharmaceutical company or within the life sciences industry in progressively responsible roles required
10 years of progressive experience within the pharmaceutical industry with a preferred minimum of 5+ years experience in global research & development, clinical development or medical affairs
Proven leadership skills in developing, direction, organizing, managing, coordination and monitoring complex processes
Ability to manage and implement change
Good written and verbal communication skills with ability to work collaboratively and independently
Good working knowledge of personal computers and office software (Word processing, spreadsheets, databases, and presentation packages)
Demonstrated ability and willingness to learn and app yew and upgraded systems to job responsibilities
Demonstrated success utilizing a variety of communication tools, from verbal communication to use of current technology, one-to-one interactions and facilitation of small group work sessions to