Associate Director, Regulatory Advertising & Promotion

Johnson & Johnson; Horsham; On-site; USD 137,000 - 236,000; Full time

Job summary

An established industry player is seeking an Associate Director for Regulatory Advertising & Promotion. This pivotal role involves overseeing compliance activities related to advertising and promotion in the healthcare sector. The ideal candidate will have extensive experience in regulatory affairs and a strong understanding of FDA regulations. You will work collaboratively with cross-functional teams to ensure compliance while supporting product launches and strategic initiatives. Join a dynamic team dedicated to innovative healthcare solutions and make a meaningful impact on patient care.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Retirement Plans

Paid Time Off

Performance Bonus

Qualifications

• 8+ years of relevant experience in regulatory affairs.
• Strong understanding of FDA promotional practices and compliance.
• Experience in pharmaceutical or biopharmaceutical industries.

Responsibilities

• Oversee regulatory advertising and promotion compliance activities.
• Conduct promotional labeling and marketing compliance reviews.
• Integrate compliance considerations into product team projects.

Skills

Regulatory Compliance

Problem Solving

Communication Skills

Knowledge of FDA Regulations

Project Management

Education

Bachelor's degree in healthcare or science

Advanced degree (PhD, Pharm D, JD, MBA)

Job description

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:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for an Associate Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization, based in Horsham, PA, New Brunswick, NJ, Raritan, NJ or Titusville, NJ.

The Associate Director, Regulatory Advertising & Promotion will:

1. Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned products.
2. 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.
3. 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.
4. 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.
5. Integrate compliance considerations into product team project development.
6. Provide input for policies, procedures and training related to Regulatory Advertising & Promotion and marketing compliance.
7. 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.
8. Conduct monitoring and observations of promotional presentations related to speaker programs and field personnel.
9. 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 relevant working experience
• A minimum of 5 years of experience in pharmaceutical and/or biopharmaceutical industry
• Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends
• Demonstrated ability with complex problem solving; excellent written and verbal communications
• A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Medical Information, Sales, Marketing, Legal, etc.

Preferred Skills & Experience:

• The ability to effectively prioritize assignments for multiple products and projects simultaneously
• Experience supporting product launches is preferred.

Other:

• The role is based in Horsham, PA and will require travel up to 25%, mainly to domestic destinations
• For current J&J employees with a proven track record of success, co-location at our Titusville, NJ campus will be considered. This is up to the discretion of management.

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 and Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and require accommodations, please email [e-mail] or contact AskGS for assistance.

The anticipated base pay range for this position is :

137,000-235,750

Additional Description for Pay Transparency:

The Company maintains competitive, performance-based compensation programs. This position is eligible for an annual performance bonus, awarded at the discretion of the Company, based on individual and company performance. Benefits include medical, dental, vision, life insurance, disability, legal insurance, retirement plans, and paid time off. More details are available at http://www.careers.jnj.com/employee-benefits.