Director, Regulatory Advertising & Promotion at Johnson & Johnson in Titusville, NJ
Johnson & Johnson is recruiting a Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization, located in Titusville, NJ. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. With $82.6 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 260 Johnson & Johnson operating companies employing over 135,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. 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 7 years experience at a Health Authority, pharmaceutical or biopharmaceutical industry is required. Bachelor's degree in a health or science-related field and/or an Advanced degree (PhD, Pharm D, JD, MBA, etc.) Regulatory Advertising & Promotion experience is highly preferred. A demonstrated 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. Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required. People Management experience (including supervisory responsibilities) is highly preferred Ability 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 Strong written and verbal communication skills, organizational skills, program management skills, complex problem-solving and analytical/process skills is required. Strong leadership and interpersonal skills are required Consistent track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas is required The position will require up to 25-30 % travel The position is located in Titusville, NJ Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization Johnson & Johnson International (6078) Job Function Regulatory Affairs Requisition ID 2206002109W
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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 7 years experience at a Health Authority, pharmaceutical or biopharmaceutical industry is required. Bachelor's degree in a health or science-related field and/or an Advanced degree (PhD, Pharm D, JD, MBA, etc.) Regulatory Advertising & Promotion experience is highly preferred. A demonstrated 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. Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required. People Management experience (including supervisory responsibilities) is highly preferred Ability 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 Strong written and verbal communication skills, organizational skills, program management skills, complex problem-solving and analytical/process skills is required. Strong leadership and interpersonal skills are required Consistent track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas is required The position will require up to 25-30 % travel The position is located in Titusville, NJ Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization Johnson & Johnson International (6078) Job Function Regulatory Affairs Requisition ID 2206002109W
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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