Johnson & Johnson Careers
Head, Regulatory Advertising & Promotion Actelion
Requisition ID: 2972190912
As Head, Regulatory Advertising & Promotion Actelion, you will provide direction and oversight of regulatory advertising & promotion compliance activities for assigned areas. You will 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. You will also ensure compliant growth by strategically supporting the business and addressing problems/opportunities by generating alternatives to achieve desired outcomes. You will lead a team and be a member of multi-disciplinary teams such as Copy Approval Committees, Business Leadership Boards, Global Regulatory Teams, Product Labeling Teams and Compound Development Teams.
In this role, you will integrate regulatory advertising and promotion considerations into product team project development. You will also provide input for policies, procedures and training related to Regulatory Advertising & Promotion and marketing compliance. You will 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. You will also conduct monitoring and observations of promotional presentations related to speaker programs and field personnel, identify issues 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. You should 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 communication goals.
- 10+ years of regulatory, advertising /promotions experience is required with a Bachelor’s degree in a health or science-related field and/or an Advanced degree (PhD, Pharm D, JD, MBA, etc.) or Regulatory Advertising & Promotion experience is highly preferred.
- Experience at a Health Authority, pharmaceutical or bio-pharmaceutical industry is required.
- Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends is required.
- Prior people management experience is preferred.
- A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, Quality, etc. is desirable.
- Demonstrated ability with complex problem solving; excellent written and verbal communications required.
- Consistent track record in delivering results, self-starter and ability to manage complexity and deals well with ambiguity and new areas.
This position is based in San Francisco, CA and requires occasional overnight travel (approximately 20% annually).
Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job; it is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates, and should not be considered absolute. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.
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.
United States-California-San Francisco-
Johnson & Johnson International (6078)
Health Care Compliance