At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Legal & Compliance

Job Sub Function:

Law Business Partners

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Titusville, New Jersey, United States of America, Washington, District of Columbia, United States of America

Job Description:

We are searching for the best talent for a Senior Counsel, Regulatory Law, to be located in New Brunswick, NJ; Titusville, NJ; Horsham, PA; or Washington D.C.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine.

Purpose: This lawyer will primarily provide regulatory legal support for the Research & Development (“R& D”), Quality and Johnson & Johnson Innovative Medicine, our pharmaceuticals business.

You will be responsible for:

• Provide specialized regulatory legal counsel and strategic advice on a wide range of regulatory and compliance issues for R& D and Quality organizations and Innovative Medicines. Initial assignment within Johnson & Johnson Innovative Medicine will focus upon the Oncology therapeutic area.
• For R& D, provide strategic regulatory legal advice on proposed non-product-specific R& D business initiatives in select key areas and collaborate with global R& D business partners on developing appropriate and compliant solutions. Key areas may include research-related communications supporting clinical trial recruitment and retention, plain language summaries, and publications, research frameworks such as collaborations and investigator-initiated studies, and clinical trial operations (including pre-approval and post-trial access, clinical trial agreement regulatory provisions, innovative clinical trial support arrangements, informed consent, and clinical trial registration and disclosure).
• For Quality, provide proactive advice and legal counsel to the Quality organization for the Johnson & Johnson Innovative Medicine sector and other business and cross-functional partners on laws, regulations, industry standards, and company policies on select issues, escalations, field actions, investigations, inspections and health authority communications arising throughout the product lifecycle related to product quality and compliance (including Good Manufacturing Practice, Good Clinical Practice, Good Documentation Practice, Good Laboratory Practice, Drug Supply Chain Security Act and Drug Enforcement Administration requirements), Supply Chain security, product diversion and counterfeiting, and anti -bribery requirements impacting Supply Chain.
• For Johnson & Johnson Innovative Medicine, advise clients on U.S. FDA regulatory matters and compliance with laws, regulations, rules, guidance, industry standards and company policies and procedures that arise throughout the product life-cycle, including in the areas of product development, regulatory submissions and strategy, advertising and promotion, social media, data, research and development, quality system compliance, and life-cycle management strategies. Provide advice and collaborate on U.S. marketing and sales activities and programs, including review of advertising and promotional materials as part of the company review and approval process as part of a cross-functional team, and counsel on patient access and support. Review and monitor paralegal review of U.S. promotional and educational materials as part of a cross-functional team.
• Provide legal counsel on U.S. health care, fraud and abuse laws, including the U.S. Federal Anti-Kickback Statute, related health care legal obligations, industry codes, such as the PhRMA Code on Interactions with Health Care Professionals, and on legal requirements related to privacy and data protection.
• Engage in key policy and regulatory issues impacting our R& D, Quality and Johnson & Johnson Innovative Medicine through involvement in trade associations, industry organizations, and participation on cross-functional teams assessing and planning for new policy or regulatory developments. Advise on policy positions and help J& J proactively shape the external environment to maintain access to our medications, efficient supply chains and improve the health of patients consistent with Johnson & Johnson’s Credo.
• Be a member of the GLO and the Global Regulatory Legal Team and work closely with other GLO colleagues around the world to provide consistent and meaningful legal support to the Johnson & Johnson Innovative Medicine sector as well as the enterprise. Provide global and enterprise connectivity on common regulatory legal issues and their application.
• Partner with the Johnson & Johnson Health Care Compliance and Privacy Organizations to assess risk, develop policies, and conduct internal training. Collaborate with Quality colleagues in training on compliance areas including Good Manufacturing Practice, Good Clinical Practice, Good Documentation Practice, and Good Laboratory Practice,
• Travel within the United States up to 10% of the time.

Qualifications/Requirements:

• A J.D or LL.M. Degree 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 10 years of experience advising business partners in the life-sciences industry while working at a law firm, in a regulatory agency, or as an in-house lawyer on regulatory matters, including U.S. FDA policies and enforcement in the area of promotional activity, is required. Candidate must have significant experience in a variety of areas of U.S. FDA regulatory law for investigational as well as marketed products. Prior experience and expertise in counseling on pharmaceuticals and biologics, including personalized medicines, is preferred. Seasoned R& D and/or GxP experience is preferred.
• Demonstrate an ability to act independently with minimal supervision, exercising sound judgment and strategic thinking to guide the business in complex legal matters.
• Displays an ownership mentality and enthusiasm for tackling new challenges.
• 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 and have strong presentation skills with a consultative style who is comfortable strategically counseling senior business leaders and participating on cross-functional teams.
• Expertise advising clients on Health Care Compliance obligations, including the U.S. health care fraud and abuse laws, including the U.S. Federal Anti-Kickback Statute, is strongly 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.
• 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. FDA, is strongly preferred.
• Have a positive attitude and the ability to work collaboratively on teams and with GLO colleagues and business partners.
• Be able to work independently in a fast-paced environment, with global teams located in multiple time zones.
• This position will be located in New Brunswick, N.J., Titusville, N.J., Horsham, P.A., or Washington D.C. but may require travel to other locations.

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.

Johnson and Johnson is committed to providing interview process that are inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$146, 000-$251, 850

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year