The Associate Corporate Counsel, Global R&D, reports to the Sr. Corporate Counsel, R&D and Global Contracting, and is accountable for advising and collaborating with the global R&D business on a broad range of R&D-related activities, including pre-clinical and clinical studies, regulatory engagement strategy, and compliance with R&D-related regulations, including all applicable GxP requirements. As a dedicated strategic legal partner, this person interacts with leadership and other stakeholders from various cross-functional teams and has client responsibility on a broad range of Global R&D-related activities and clinical development programs from early to late stage. Ideal candidates have strong leadership skills and experience providing R&D-related legal support in the areas noted and in advising stakeholders in all levels of an organization, including senior management, and the ability to lead and/or play a significant role in special projects and on cross-functional teams dealing with complicated legal issues. The Associate Corporate Counsel must be capable of resolving complex strategic issues in creative and effective ways with minimal direct oversight and have an appreciation of the immediate and long-term impact that legal decisions may have on the overall global business.
To be successful in this role, the candidate must be a strong collaborator, someone who appreciates the strength of a team, and the ability and willingness to value and respect differences.
Key Job Responsibilities: Provide legal counsel on issues impacting clinical research and development such as informed consent, CRO arrangements, patient recruitment activities, contract arrangements with investigators, clinical research vendors, and other collaborative research groups, IND submissions, GxP matters, and many other legal aspects of regulatory compliance involved in R&D activities;Utilize business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risk within areas of responsibility and formulate and communicate compliant and practical solutions that meet business objectives;Collaborate with members of the Global Contracting group to review, interpret, negotiate, and draft various clinical study-related agreements, technology transfers, and licensing agreements with academic institutions and strategic partners. Provide guidance and serve as escalation-point from Global Contracting for R&D-specific issues in these agreements;Create and deliver effective training and other presentations to stakeholders and other members of the department on legal topics and other relevant subjects;Proactively identify the need for, draft, and provide legal advice on corporate policies, SOPs, and guidance documents;Serve as part of matrixed teams involved in R&D-related activities and collaborate effectively, find common ground, and build alignment with relevant stakeholders;Partner with other members in the Legal and Compliance Departments to ensure consistency in approach across areas of the overall business;Contribute to strategic planning with partners and colleagues to optimize the implementation of clinical studies and other medical research activities;Keep informed of new laws, regulations, and industry trends affecting the organization;Establish strong partnership relationships with global research and development teams, as well as key cross functional teams engaged in development activities characterized by a high-level of collaboration and mutual respect;Drive increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the business and other key stakeholders;Participate in special projects and cross-functional teams that have a broader impact on the organization;Partner with Legal Department colleagues in executing and enhancing corporate and department objectives;Create transparent and reliable lines of communication with legal department leadership and business partners, ensuring that project developments are shared in a timely manner;Review and provide feedback on proposed regulation or legislation and assess impact on Jazz business operations;Define, direct, and manage the work of outside counsel and other legal vendors.Required Knowledge, Skills, and Abilities: Experience providing legal advice and counsel to clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both;Experience advising clients on FDA regulatory compliance, GxP, and other matters relating to clinical trials and research and development activities;Understanding of pharmaceutical industry and regulatory enforcement environment, including fluency in understanding of anti-kickback laws, fraud and abuse laws, and regulations and regulatory guidance by the U.S. Food & Drug Administration and other regulatory authorities relating to clinical trials, medical activities, pharmacovigilance, manufacturing, and regulatory interactions;Must be self-motivated, proactive, strategic, a good listener, and exhibit excellent judgment;Capable of delivering difficult messages and providing legal advice with tact, poise, and diplomacy;Ability to influence without authority, as well as manage multiple projects, while remaining organized and delivering successfully in a fast-paced, evolving environment;Must be a strong collaborator and adept at understanding the motivation and needs of others and effectively communicating with a diverse audience, including senior leaders, in a manner that generates confidence and support for proposals/recommendations;Legal analysis and advice is well thought out and accurate, potential legal and compliance issues are consistently identified, and the Associate Corporate Counsel, Global R&D takes ownership and responsibility for legal issues that arise within the function(s) and client groups supported;Demonstrated ability to proactively independently identify, analyze, and render legal advice on complex business issues and general corporate matters;A global business enterprise view, with recognition of the potential operational implications of corporate legal issues;Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to company;Excellent verbal and written communication skills;Demonstrates and models the Jazz values: Focus on delivering solutions that help patients;Direct and honest in communication and feedback;Demonstrates consistency between words and actions;Develops and sustains cooperative productive partnerships;Demonstrates passion for the job, organization, and company;Demonstrates strong accountability for results, performance, standards, and continuous improvement;Open to new approaches and embraces change.Required/Preferred Education and Licenses: U.S. Juris Doctorate (J.D.) degree; active law license in at least one U.S. jurisdiction.
#J-18808-Ljbffr