Easter Seals Jobs

Associate Director, Regulatory Advertising & Promotion - 2406201314W

Description

Johnson & Johnson is currently seeking an Associate Director, Regulatory Advertising & Promotion to join our Health Care Compliance organization located in Titusville, NJ.

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/.

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:

The Associate Director, Regulatory Advertising & Promotion will:

• 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 in compliance with 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.

• 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, Health Care 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, Health Care Compliance Teams, Global Regulatory Functional Teams, Product Labeling Teams and Compound Development Teams.

• Integrate compliance considerations into product team project development.

• Provide input for policies, procedures and training related to Regulatory Advertising & Promotion and marketing compliance.

• When appropriate, serve as primary contact for OPDP for assigned product related new product launches, Direct-to-Consumer advertisements and enforcement actions. 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.

Qualifications

Education

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

• An advanced degree (PhD, Pharm D, JD, MBA, etc.) is desirable.

Required Skills &Experience

• A minimum of 8 years of professional business experience is required.

• A minimum of 5 years of experience in pharmaceutical and/or biopharmaceutical industry is required.

• A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, etc.

• Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is preferred.

• Demonstrated ability with complex problem solving; excellent written and verbal communications are required.

Preferred Skills & Experience

• The ability to effectively prioritize assignments for multiple products and projects simultaneously

• Experience supporting product launches is preferred.

Other

• Ability to travel up to 25%, mainly to domestic destinations.

The anticipated base pay range for this position is $135,000-$232,300. 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 23, 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 .

Primary Location NA-US-New Jersey-Titusville

Organization Johnson & Johnson Services Inc. (6090)

Job Function Regulatory Affairs

Req ID: 2406201314W