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Posted: Monday, February 12, 2018 10:35 AM

Description

Johnson & Johnson is recruiting for a Regulatory Advertising & Promotion Director to support the Health Care Compliance & Privacy Group.

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.

With $71.9 billion in 2016 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 and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 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

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 Committees, Business Leadership Boards, 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.
• Clearly articulate any potential risks, along with rationales and anticipated likely outcomes.
• Facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified communication goals.


Qualifications
• A minimum of a Bachelor’s degree is required; an advanced degree or a minor in a health or science-related field is preferred.
• A minimum of 10 years of experience at a Health Authority or within the pharmaceutical or biopharmaceutical industry is required.
• Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.
• Regulatory Advertising & Promotion experience is preferred.
• Prior people management experience is preferred.
• 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 preferred.
• Demonstrated ability with complex problem solving and, excellent written and verbal communications is required.
• Proven track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas is required.
• Must be able to travel overnight, approximately 5% of the time.


Primary Location
United States-New Jersey-Titusville
Organization
Johnson & Johnson International (6078)
Job Function
Health Care Compliance
Requisition ID
0045180117

Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=0045180117&lang=en


• Location: South Jersey, Titusville

• Post ID: 53685417 newjersey
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