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Senior Counsel, Regulatory Law Job

Company Name:
Johnson & Johnson (6067)
New Brunswick, NJ, US
Johnson & Johnson companies are equal opportunity employers.
Senior Counsel, Regulatory Law
Description
The Johnson & Johnson Law Department is recruiting for a Senior Lawyer, Regulatory Law, to be located at Johnson & Johnson World 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 $65 billion in 2011 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 119,000 people in 60 countries throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
This Senior Lawyer will provide legal support to client groups in the pharmaceutical sector. The Senior Lawyer will be responsible for advising clients on FDA regulatory matters and compliance with laws, regulations and company policies in the areas of advertising and promotion, clinical research, product development, and quality. He/she will provide strategic legal advice and counsel on U.S. Health Care Fraud and Abuse Laws, including the Federal Anti-Kickback Statute, and related health care legal obligations. Additionally, he/she will advise on marketing and sales activities and programs, including review of advertising materials, and will work with clients on developing appropriate and compliant strategies for interacting with health care providers and payors. He/she will also advise clients on life cycle management strategies, and on research and development programs, including the co-development of drugs and diagnostics.
Qualifications
A Juris Doctor Degree and admission to (and current good standing with) the bar of at least one state or the District of Columbia is required. A minimum of 5 years of experience in FDA regulatory matters and health care law practice is required, with a focus on pharmaceutical and biotechnology products preferred. Experience is also required in providing counsel in the review of labeling materials and other aspects of regulatory strategy for product submissions and preference is given to those that have experience with exclusivity strategies. Significant experience advising on health care compliance obligations, including U.S. Health Care Fraud and Abuse Laws, is required. Experience in the regulation of clinical trials, human subject protection and manufacturing, such as Good Manufacturing Practices and Good Clinical Practices, is strongly preferred. The successful candidate will have excellent strategic and analytical skills, strong communication and presentation skills, and the ability to work effectively both independently and on teams. This position requires up to 10% travel. This position is located in New Brunswick, NJ.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
J2W:BIO
J2W:MZ
J2W:NSJ
Primary Location:
North America-United States-New Jersey-New Brunswick
Organization:
Johnson & Johnson (6067)
Job Function:
Corporate Law
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement

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