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Director, Regulatory Advertising & Promotion - 2406200829W

Description

Johnson & Johnson is currently seeking a Director, Regulatory Advertising & Promotion to join our Health Care Compliance Organization located in Horsham, PA. It is highly beneficial to be co-located with key business partners. Relocation expenses will not be paid/reimbursed.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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 is required.

• An advanced degree (PhD, Pharm D, JD, MBA, etc.) is preferred.

• 7-10 years of business experience is required.

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.

• 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.

• Experience supporting product launches is required.

Preferred:

• People Management and supervisory experience is highly preferred.

Other:

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

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 .

Primary Location NA-US-Pennsylvania-Horsham

Organization Johnson & Johnson Services Inc. (6090)

Job Function Regulatory Affairs

Req ID: 2406200829W