Description

Description

Johnson & Johnson is recruiting for a Director, Regulatory Advertising & Promotion, located in Titusville, NJ! Secondary locations include Horsham, PA; Raritan, NJ; or New Brunswick, NJ. It is highly helpful 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.
Key Responsibilities:

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

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.
• People Management and supervisory experience is highly preferred.
• Strong written and verbal communication skills, organizational skills, program management skills, complex problem-solving and analytical/process skills.

Other:

• The position will require up to 25-30% travel, mainly to domestic destinations.

The base pay range for this position is $137,000 -$235,750. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.