Manager, Regulatory Advertising & Promotion

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 Med Tech, 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
** 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, Titusville, New Jersey, United States of America
Job Description: We are searching for the best talent for Manager, Regulatory Advertising & Promotion to join our Health Care Compliance organization. This position can be based in Horsham, PA, Titusville, NJ or New Brunswick, NJ. Please note that this position is not eligible for relocation and that onsite presence is required three days a week.

• 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 following 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.
• Integrate compliance considerations into product team project development.
• 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, Health Care 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, Health Care Compliance Teams, Global Regulatory Functional Teams, Product Labeling Teams and Compound Development Teams.
• Partner with business and key stakeholders to enhance flexibility in review pathways to compliantly enable greater agility and speed to impact
• Integrate regulatory and compliance considerations into digital/social media strategies
• Evaluate and analyze competitive landscape from a digital/social media perspective for assigned therapeutic area
• Serve as primary contact for OPDP for assigned product related new product launches, Direct-to-Consumer advertisements and enforcement actions, when appropriate. 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.
• 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.

Education:

• A bachelor’s degree is required.

• A minimum of 4 years of overall experience with 2 years of experience in the pharmaceutical and/or biopharmaceutical industry are required.
• Demonstrated ability with complex problem solving; excellent written and verbal communications are required.
• Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.

• An advanced degree (PhD, Pharm D, JD, MBA, etc.) is desirable.
• Experience supporting product launches is preferred.
• A demonstrated…