Johnson & Johnson is recruiting for an Associate Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization, based in Horsham, PA.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products, and services to advance the health and well-being of people.
With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
The Associate Director, Regulatory Advertising & Promotion will:
- Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned Oncology 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, 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
- 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
- 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 is required
- A minimum of 5 years of experience in the pharmaceutical and/or biopharmaceutical industry is required
- Demonstrated ability with complex problem solving; excellent written and verbal communications is required
- 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
Preferred Skills & Experience:
- 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.is preferred
- Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends is preferred
- The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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
United States-Pennsylvania-Horsham-800/850 Ridgeview Drive
Johnson & Johnson Services Inc. (6090)