Manager, Regulatory Advertising & Promotion - Johnson and Johnson

Johnson & Johnson is currently seeking a Manager, Regulatory Advertising & Promotion to join our team located in Titusville, NJ, Horsham, PA, Raritan, NJ or New Brunswick, NJ.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.
Key Responsibilities:

• Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned products.
• Conduct regulatory promotional labeling and marketing compliance reviews in the R&D and commercial arenas to help ensure that activities and communications are consistent with product labeling, are adequately supported and are following applicable laws, regulations and policies related to advertising & promotion of prescription products.
• Help ensure compliant growth under applicable laws, regulations, guidelines, and company policies by strategically supporting the business and addressing problems/opportunities by generating alternatives to achieve desired outcomes.
• Integrate compliance considerations into product team project development.
• Conduct Regulatory Compliance reviews as a member of multi-disciplinary team consisting of RAP, Legal, Medical and HCC in the review of strategies, activities & communications which include but are not limited to the following: External Facing Activities and Materials Including Healthcare Professional & Consumer advertising and promotion; Core Visual Aides & Journal Advertisements, Websites, Healthcare Economic Information, Formulary and Managed Care Organization Information, External corporate communications (Press Releases), Medical conventions, New product/indication launches, Advisory Boards, Dear Doctor letters; Internal-Facing Activities and Materials Including Operating Company Brand Communications and Activities, HealthCare Compliance Committee Presentations, Sales Training Review, Internal sales & Marketing communications, Business Plans, Global Marketing, Speaker Bureau Presentations, Creative Concept Review, Compliance and FDA Update training, Promotional Review Copy (PRC) Meetings, HealthCare Compliance Teams, Global Regulatory Functional Teams, Product Labeling Teams and Compound Development Teams.
• Partner with business and key stakeholders to enhance flexibility in review pathways to compliantly enable greater agility and speed to impact.
• Integrate regulatory and compliance considerations into digital/social media strategies.
• Evaluate and analyze competitive landscape from a digital/social media perspective for assigned therapeutic area.
• Serve as primary contact for OPDP for assigned product related new product launches, Direct-to-Consumer advertisements and enforcement actions, when appropriate. Responsible for the timely submission of promotional materials to OPDP.
• Conduct monitoring and observations of promotional presentations related to speaker programs and field personnel.
• Identify issues and facts that may be impacted by and subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends; fraud and abuse laws and HCC policy); and helping to develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcome outcomes.
• Clearly articulate any potential risks, along with rationales and anticipated likely outcomes.
• Facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified communication goals.

Education:

• A minimum of a Bachelor's degree in a healthcare or science related field is required.

Experience and Skills:

Required:

• A minimum of 4-6 years of overall experience with 2 years of experience in the pharmaceutical and/or biopharmaceutical industry are required.
• Demonstrated ability with complex problem solving; excellent written and verbal communications are required.

Preferred:

• An advanced degree (PhD, Pharm D, JD, MBA, etc.) is desirable.
• Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.
• Experience supporting product launches is preferred.
• A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Regulatory Affairs, Sales, Marketing, Legal, etc. is preferred.

Other:

• Must be able to travel 10% of the time to domestic destinations, depending on business need.

The anticipated base pay range for this position is $113,000-$195,500. 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)).

• Employees are eligible for the following time off benefits:

o Vacation - up to 120 hours per calendar year

o 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

o Holiday pay, including Floating Holidays - up to 13 days per calendar year

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

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

This job posting is anticipated to close on July 18, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .