Johnson & Johnson is on FGB’s Best Companies for Women of 2020.
FGB'ers gave this company a 4.3/5 in overall job satisfaction
FGB’ers working at Johnson & Johnson rated their manager’s support a 4.4/5
Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
The Johnson & Johnson Law Department is recruiting for a Senior Counsel, Regulatory Law to support the Johnson & Johnson Medical Devices Companies. This position will be based at Johnson & Johnson World Headquarters in New Brunswick, NJ o Washington, D.C. In this role you will: • Provide specialized legal counsel and strategic advice on a wide range of regulatory and compliance issues to support the development of innovative med tech products, services, and solutions, including digital health and robotically-assisted surgical devices. • Advise on legal issues throughout the medical device lifecycle related to regulatory strategy, clinical research, premarket clearance and approval, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, post-market surveillance, and quality system compliance. • Guide quality and regulatory teams on interactions with regulators, hospitals, and physicians and provide legal support during regulatory inspections and discussions of potential field actions. • Review and supervise paralegal review of United States promotional and educational materials as part of a cross-functional team. • Advise on interactions with health care providers, payors, and government officials in compliance with fraud and abuse laws such as the U.S. Anti-Kickback Statute and industry codes such as the AdvaMed Code of Ethics. • Engage in external regulatory and policy initiatives with trade associations and Johnson & Johnson policy teams. • Be a member of the Global Regulatory Legal Team and collaborate with Johnson & Johnson Law Department colleagues around the world. • Partner with the Johnson & Johnson Health Care Compliance and Privacy Organizations to assess risk, develop policies, and conduct internal training. • Travel within the United States up to 10% of the time. Qualifications The successful candidate will: • Have a J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia. • Have at least 7 years of experience in the life sciences industry while working at a law firm, in a regulatory agency, and/or as an in-house lawyer. • Experience advising clients on U.S. regulatory and compliance matters and medical device regulation, including data rights, protected health information (PHI), and privacy and cybersecurity issues. • Preferably have experience and an understanding of the role of big data, machine learning, and Artificial Intelligence (AI) in driving business/clinical insights information systems, data management, website and mobile app development, and Software as a Medical Device. • Demonstrate excellent strategic and analytical skills and the ability to help business partners find creative and compliant solutions to novel issues. • Be an effective communicator with a consultative style who is comfortable interacting with senior business leaders and participating on cross-functional teams. • Have a positive attitude and the ability to work collaboratively within teams and with legal colleagues and business partners at all levels of seniority. • Be able to work independently in a fast-paced environment, with global teams located in multiple time zones. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-New Jersey-New Brunswick-One Johnson & Johnson Plaza Other Locations North America-United States-District of Columbia-Washington Organization Johnson & Johnson (6067) Job Function Legal Requisition ID 2206012691W
Child care benefits
Short term disability