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In-House
Attorney
Min 5 yrs required
Senior Counsel, Regulatory Law, Quality and Supply Chain Duties: Be a member of the Global Regulatory Law Group and provide specialized legal counsel and strategic advice to various groups in the Quality and Supply Chain Organizations across the business sectors. Provide legal counsel to senior management and other business and cross-functional partners on laws, regulations, industry standards, and company policies on issues arising throughout the product lifecycle related to product quality and compliance. Develop and conduct training to improve client’s knowledge on a range of health care compliance and other compliance areas such as Good Manufacturing Practice, Good Clinical Practice, Good Documentation Practice, and Good Laboratory Practice and legal issues that support important business strategies. Collaborate with other legal colleagues on Global Trade Compliance issues, including export control license requirements and OFAC compliance. Effectively provide and coordinate legal support, participate in cross-functional teams and collaborate with business and Law Department management on key matters. Counsel business and other internal partners on significant legal, regulatory and policy developments related to quality and compliance to ensure that the support of J&J is agile and appropriately adapted to a constantly evolving environment. Engage in key policy and regulatory issues impacting our customer relationships and business strategies through involvement with trade associations, participation on cross-functional teams assessing and planning for the new policy or regulatory developments, advising on policy positions and helping J&J proactively shape the external environment to maintain access to the medications and improve the health of consumers consistent with J&J’s Credo. Work closely with global Law Department colleagues to provide efficient, effective legal support.
Qualification and Experience
Qualifications: A J.D. or LL.M. with admission to and current good standing with the Bar of at least one state or the District of Columbia is required. 5+ years of experience or equivalent advising manufacturers of FDA-regulated products on matters related to product quality and compliance is required. Experience in a law firm or company counseling clients in the life sciences industry on quality and compliance regulatory matters or in a regulatory agency, such as the U.S. Food & Drug Administration, is required. Experience interacting and collaborating with teams across business functions and regions is preferred. The successful candidate will have a positive approach, excellent strategic and analytical skills and strong interpersonal skills, who is comfortable interacting with senior business leaders.
Requisition ID: 2105976847W
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