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Senior Corporate Counsel, Global R&d
Refer job# UNXG164443
Senior Corporate Counsel, Global R&D Responsibilities: 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; 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; and 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 business operations; Define, direct, and manage the work of outside counsel and other legal vendors; and

Qualifications: U.S. JD Degree; active law license in at least one U.S. jurisdiction. 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; 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; Ability to execute all aspects of role independently with little supervision and with the highest integrity and ethics; Must be self-motivated, proactive, strategic, a good listener, exhibit excellent judgment; Capable of delivering difficult messages and providing legal advice with tact, poise, and diplomacy; Possess the ability and willingness to advance new ideas and recognize when decisions may have a broad impact on the global organization; Ability to lead others, as well as lead and manage multiple projects, while remaining organized and delivering successfully in a fast-paced, evolving environment; Consistently take action and drive issues to closure and hold self and others accountable for achieving results; 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 Senior Corporate Counsel, R&D takes ownership and responsibility for legal issues that arise within the function(s) and client groups supported; Must consistently demonstrate leadership behaviors and ability within the R&D Legal team, the Legal Department, and within the broader organization; Demonstrated experience working in a matrixed business environment, managing multiple commitments while prioritizing conflicting demands, maintaining focus on corporate objectives and providing quality customer service; 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.
This particular job is currently not active. However, since our clients regularly share with us similar and other job openings, we strongly recommend that you submit your resume. We shall review your resume and get in touch with you as soon as a suitable vacancy comes up to further discuss your interest in exploring the opportunity. Assisting you is our highest priority.

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