As a Senior Counsel, Regulatory Law, you will:
- Be a member of the Global Regulatory Legal Team and provide specialized legal counsel to assigned therapeutic area(s) and initiatives in support of the Pharmaceutical Sector of Johnson & Johnson. This position will primarily provide regulatory legal support to Janssen Oncology.
- 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, regulatory submissions, advertising and promotion, research, and quality.
- 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 will work with clients to develop appropriate and compliant strategies for interacting with healthcare providers, payors, and other stakeholders.
- Collaborate with and advise other functional teams supporting the Business on regulatory issues.
- 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 the Janssen pharmaceutical companies of Johnson & Johnson.
- A Juris Doctor Degree 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.
- A minimum of 5 years of experience advising clients on FDA regulatory matters is required; a focus on pharmaceutical and biotechnology products is strongly preferred. Experience in cell or gene therapy is preferred.
- Experience is required in the legal review of labeling materials and counseling on other aspects of regulatory strategy for product submissions and life-cycle management is required.
- 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.
- Experience working with alliance and/or co-promotion partners is helpful, but not required.
- 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 are required.
- This position will require occasional travel to our Titusville and New Brunswick locations.
Johnson & Johnson Services Inc. (6090)