Job Description

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 MedTech, 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 https://www.jnj.com
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
:
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.
Key Responsibilities:

• 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, 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.
• 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.

Qualifications
Education:

• A bachelor's degree is required.

Experience and Skills:
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.

Preferred:

• An advanced degree (PhD, Pharm D, JD, MBA, etc.) is desirable.
• Experience supporting product launches is preferred.
• A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Regulatory Affairs, Sales, Marketing, Legal, etc. is preferred.

Other:

• A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Regulatory Affairs, Sales, Marketing, Legal, etc. is preferred.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
The anticipated base pay range for this position is :
$115,000-$197,800
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits Co-Ops and Intern Positions: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year Co-Ops and Interns are eligible to participate in the Company's consolidated retirement plan (pension) Positions Represented by CBA: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. 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.

Skills Required