Senior Counsel, Regulatory Law

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Legal & Compliance

Job Sub Function:

Law Business Partners

Job Category:

Professional

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Senior Counsel, Regulatory Law - Innovative Medicine to be based in Titusville, NJ. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose: This role will primarily provide regulatory legal support for CAPLYTA, a key neuroscience asset within Johnson & Johnson Innovative Medicine (J&J IM), as well as support additional priority brands across the J&J IM portfolio.

You will be responsible for:

• Primarily provide specialized regulatory legal counsel and strategic guidance across regulatory and compliance matters for CAPLYTA, including support for the integration of Intra‑Cellular Therapies, Inc. (ITCI).

• Advise clients on U.S. FDA regulatory matters and compliance with laws, regulations, rules, guidances, 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.

• Be a member of the GLO and the GRLT and work closely with other GLO colleagues around the world to provide consistent and meaningful legal support to the J&J IM 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.

• 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.

• Experience supporting complex business arrangements in the life sciences sector—such as strategic alliances, mergers and acquisitions, divestitures, and licensing and collaboration agreements—including providing strategic regulatory legal counsel to senior leaders through periods of integration, portfolio evolution, growth, and rationalization, in support of compliant, risk‑based decision‑making across the product lifecycle 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 in 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 Titusville, NJ, but may require travel to other locations.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is 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  ([email protected]) or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Business Agility, Business Alignment, Commercial Laws, Compliance Management, Consulting, Corporate Governance, Developing Others, Dispute Resolution, Inclusive Leadership, Industry Analysis, Lawyering, Leadership, Leading Change, Legal Services, Negotiation, Representing, Strategic Thinking

 

 

The anticipated base pay range for this position is :

$150,000.00 - $258,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits