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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

Job Description:

We are searching for the best talent for a **Director, Regulatory Advertising & Promotion** to be based in Horsham, PA. The primary location will be Horsham, PA with the option to work from a secondary location (Titusville, NJ; Raritan, NJ; or New Brunswick, NJ) once a week.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine.

You will be responsible for:

+ Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned areas.

+ Lead a team of regulatory advertising and promotion professionals and provide leadership to help ensure that activities and communications are consistent with product labeling, 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.

+ Member of multi-disciplinary teams such as Copy Approval Committees, Business Leadership Boards, Global Regulatory Teams, Product Labeling Teams and Compound Development Teams.

+ Create and drive strategy and approach to deliver regulatory advertising and promotion considerations into product team project development.

+ Strategically provide direction and 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 goals through an agile way of working and active collaboration with team leads.

+ Proactively identify challenges and facts that are 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 help develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcome outcomes.

+ Provide strategic input into 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.

+ Collaborate with peers and key business leaders to actively support new business models and growth strategies for assigned businesses.

+ Serve as an engaged member of the RAP LT with responsibilities for providing updates on assigned businesses, driving consistency and alignment, and providing oversight of projects and initiatives to advance the promotional compliance framework.

+ Conduct monitoring and observations of promotional presentations related to speaker programs and field personnel.

+ Be responsible for engaging in a variety of tasks and project initiatives, including many that call for sound judgment and independent initiative.

Qualifications/Requirements:

+ A minimum of a Bachelors’ Degree in a healthcare or science related field with 10 years of business experience is required.

+ An advanced degree (PhD, Pharm D, JD, MBA, etc.) with a minimum of 7 years of related experience is preferred.

+ Experience at a Health Authority, pharmaceutical or biopharmaceutical industry is required.

+ Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.

+ Strong leadership and interpersonal skill to lead a matrixed team supporting various business functions is required.

+ Ability to advise senior leaders and key stakeholders on business initiatives or complex promotional compliance issues is required.

+ Proven ability to collaborate across all levels of the organization, negotiate and influence business decisions, and work towards solutions to drive compliant growth is required.

+ Consistent track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas is required.

+ Experience supporting product launches is required.

+ Proven track record of successful business experience in other related functional areas, such as Health Care Compliance, Medical/Scientific Affairs, Sales, Marketing, Legal, etc. is desirable.

+ Strong written and verbal communication skills, organizational skills, program management skills, complex problem-solving and analytical/process skills is highly preferred.

+ People Management and supervisory experience is highly 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 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$146,000-$251,850

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)). This position is eligible to participate in the Company’s long-term incentive program. 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. http://www.careers.jnj.com/employee-benefits 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.