Senior Counsel Regulatory Law, Medical Device(Job Number: 1309180126)
The Johnson & Johnson Law Department is recruiting for a Senior Counsel, Regulatory Law, to be located at Johnson & Johnson Headquarters in New Brunswick, NJ.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $71.9 billion in 2016 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
As the Senior Counsel, Regulatory Law, you will:
• Be a member of the Global Regulatory Legal Team and provide specialized legal support for assigned companies and products in the Medical Device Sector of Johnson & Johnson.
• Be responsible for advising clients on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research, quality and other post-market requirements, with a primary focus on medical devices.
• Provide legal counsel on health care laws, including the Federal Anti-Kickback Statute, and related health care legal obligations and on legal requirements related to privacy and data protection.
• Provide advice on marketing and sales activities and programs, including review of advertising and promotional materials and competitive advertising matters, advise on product life cycle management strategies, and will work with clients to develop appropriate and compliant strategies for interacting with healthcare providers, payors, and other stakeholders.
• Provide and coordinate legal support in these fields, be a member of the relevant functional teams supporting assigned companies and interact with business and Law Department management on these matters.
• Engage in initiatives with trade associations and policy teams related to regulatory issues.
• Work closely with other Law Department colleagues to provide consistent and efficient legal support to Johnson & Johnson companies.
• A Juris Doctor Degree and admission to (and current good standing with) the bar of at least one U.S. state or the District of Columbia are required.
• A minimum of 5 years of experience advising clients on FDA regulatory matters is required, a focus on medical device products is strongly preferred.
• Experience in the legal review of promotional materials, and in counseling on other aspects of regulatory strategy for product submissions and product lifecycle, including quality/compliance counseling in areas such as Good Manufacturing Practices, Quality Systems Regulations, Good Clinical Practices, field action decision-making, and mandatory reporting obligations is required.
• Experience in advising on health care compliance obligations, including the U.S. Health Care Fraud and Abuse Laws is required.
• Experience in a law firm supporting clients in the life sciences industry on regulatory matters or in a regulatory agency, such as the U.S. F.D.A., is strongly preferred.
• Some in-house counsel experience with a medical products company and international health law experience, including familiarity with regulatory regimes in other jurisdictions, is also preferred.
• Must have excellent strategic and analytical skills, strong communication and presentation skills, and the ability to work independently and to collaborate on teams.
• Must be able to travel, approximately 10% of the time, mainly to domestic destinations.
Primary Location: North America-United States-New Jersey-New Brunswick