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, 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
A minimum of 5 years of experience in pharmaceutical and/or biopharmaceutical industry
Demonstrated ability with complex problem solving; excellent written and verbal communications
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, Sales, Marketing, Legal, etc.
Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends
The ability to effectively prioritize assignments for multiple products and projects simultaneously
The role is based in Horsham, PA and will require travel up to 25%, mainly to domestic destinations
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.