Johnson & Johnson is recruiting for a Regulatory Advertising & Promotion Director. The position will be based in Titusville, NJ.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
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. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
The Regulatory Advertising & Promotion Director will:
• Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned businesses.
• Conduct regulatory promotional labeling and marketing compliance reviews in the R&D and commercial areas 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.
• Oversee a team and be a member of multi-disciplinary teams such as Copy Approval Committee Meetings, HealthCare Compliance Teams, Global Regulatory 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.
• Serve as primary contact for OPDP for assigned products and will be responsible for timely submission of promotional materials, responses to FDA inquiries and other FDA-related matters.
• 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.
• Facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified communication goals.
• A minimum of a Bachelor’s degree is required, preferably in a health or science-related field. An advanced degree (PhD, Pharm D, JD, MBA, etc.) or Regulatory Advertising & Promotion experience is desirable.
• A minimum of 8 years of experience at a Health Authority, pharmaceutical 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, Quality, etc. is required.
• Experience as a People Manager or working in a matrix organization is required.
• Knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.
• Demonstrated ability with complex problem solving; excellent written and verbal communications required.
• Proven track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas.
• Must be able to be based in Titusville, NJ and travel overnight occasionally (approximately 10% annually).
United States-New Jersey-TitusvilleOrganization
Johnson & Johnson International (6078)Job Function
Health Care Compliance