The Johnson & Johnson Law Department is recruiting for a Senior Counsel, Regulatory Law, to be located at Janssen Pharmaceuticals in Titusville, 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 $71.3 billion in 2013 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. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.
This Senior Counsel will be a member of the Global Regulatory Legal Team and provide specialized legal support to assigned therapeutic area(s) in the Pharmaceutical Sector of Johnson & Johnson.
• The Senior Counsel will 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, and quality.
• The Senior Counsel will also 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.
• He or she will provide advice on marketing and sales activities and programs, including review of advertising and promotional materials, and will work with clients to develop appropriate and compliant strategies for interacting with healthcare providers, payors, and other stakeholders.
• The Senior Counsel will also advise clients on life cycle management strategies.
• The Senior Counsel will effectively provide and coordinate legal support in these fields, be a member of the relevant functional teams supporting assigned therapeutic area(s) and interact with business and Law Department management on these matters.
• He or she will engage in initiatives with trade associations and policy teams related to regulatory issues.
• The Senior Counsel will work closely with other Law Department colleagues to provide consistent and efficient legal support to Johnson & Johnson companies.
• A Juris Doctor Degree with admission to (and current good standing with) the bar of at least one state or the District of Columbia is required.
• The attorney must have a minimum of 5 years of experience advising clients on FDA regulatory matters, with a focus on pharmaceutical and biotechnology products preferred.
• Experience is required in the legal review of labeling materials and counseling on other aspects of regulatory strategy for product submissions and product lifecycle.
• Experience advising on health care compliance obligations, including the U.S. Health Care Fraud and Abuse Laws, is strongly preferred.
• 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.
• The ideal candidate should have excellent strategic and analytical skills, strong communication and presentation skills, and the ability to work independently and to collaborate on teams.
• The position is located in Titusville N.J. and will require some travel, approximately 10%.
United States-New Jersey-TitusvilleOrganization
Johnson & Johnson (6067)Job Function
Corporate LawRequisition ID
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.