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Senior Corporate Counsel, Global R&d
Refer job# YARL161665
 
Senior Corporate Counsel, Global R&D The candidate will provide (non-IP) legal advice and 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, CMC and GxP matters, and many other legal aspects of regulatory compliance involved in R&D activities. Intellectual property advice and counsel is not in scope for this role. Will utilize strong 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. Review, interpret, negotiate, and draft various clinical study-related agreements, technology transfers, and licensing agreements with academic institutions and strategic partners. 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 and providing support for areas outside of their primary areas of responsibility as needed. 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. Lead and drive 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. Mentor and take an interest in developing more junior members of the team and department. 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. This role may be responsible for managing one or more Legal Specialists

The candidate should have 10+ years of experience supporting clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both. Must be recognized as a technical expert in advising clients on FDA regulatory compliance, GxP, and other matters relating to clinical trials and research and development activities. Demonstrated broad and deep 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 is required. U.S. Juris Doctorate (J.D.) degree. active law license in at least one U.S. jurisdiction is preferred.
 
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