Director Regulatory Advertising & Promotion
J&J Family of Companies
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:**
People Leader
**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 a Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization. The preferred location for this position is Horsham, PA. Secondary locations are Titusville, NJ, Raritan, NJ or New Brunswick, NJ. It is highly beneficial to be co-located with key business partners. Relocation expenses will not be paid/reimbursed.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 135 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.
_Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer._
The Director, Regulatory Advertising & Promotion will:
+ 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:**
**Education:**
+ 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 and Skills:**
**Required:**
+ 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
**Preferred:**
+ 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.
**Other:**
+ The position will require up to 25-30 % travel, mainly to domestic destinations.
+ - This position has an estimated annual salary of $160,000-276,000 USD$- 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.
+ This position is eligible to participate in the long term incentive program.- 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- Work, Personal and Family Time - up to 40 hours per calendar year
**The anticipated base pay range for this position is :**
160,000-276,000 USD
Additional Description for Pay Transparency:
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