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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, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description: Johnson & Johnson is recruiting for an Associate Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization, based in Horsham, PA, New Brunswick, NJ, Raritan, NJ or Titusville, NJ.
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.
Qualifications
Education:
- 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
- Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends
- Demonstrated ability with complex problem solving; excellent written and verbal communications
- 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.
Preferred Skills & Experience:
- The ability to effectively prioritize assignments for multiple products and projects simultaneously
- Experience supporting product launches is preferred.
Other:
- 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.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is : 137,000-235,750 Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k . Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.