Johnson & Johnson Careers

Senior Regulatory Affairs Program Lead, Advertising & Promotion

Somerville, New Jersey
Regulatory Affairs

Job Description

Requisition ID: 4580180227

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Regulatory Affairs Program Lead, Advertising & Promotion. This role is based in Somerville, NJ and may require approximately 10% travel.

Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.

The Senior Regulatory Affairs Program Lead, Advertising & Promotion is a member of the ETHICON Global Strategy and Advertising & Promotion Regulatory Affairs team. The Program Lead is responsible for harmonizing the advertising and promotion regulatory compliance activities for the Ethicon Franchise, defining and implementing process improvements to support advertising and promotional plans and ensure adherence to compliance targets and efficiency, and performing advertising and promotional material reviews to ensure compliance to applicable requirements. 


• Interpret local and global regulations to ensure that Ethicon products, processes, practices and procedures comply with quality standards.
• Drive Franchise process improvements which have a significant impact for the Regulatory Affairs Department and cross-functional partners.
• Ensure compliance under applicable laws, regulations, guidelines and company policies by strategically supporting the business and addressing problems/opportunities by generating alternatives to achieve desired outcomes that enable complaint promotional activities.
• Maintain up to date knowledge of regulatory requirements and communicates changes to the Franchise in a timely manner.
• Conduct regulatory promotional labeling and marketing compliance reviews to ensure that materials and communications are consistent with product labeling, are adequately supported and comply with applicable laws, regulations and policies for all types of products, as appropriate.
• Develop and provide input for policies, procedures and training related to advertising and Promotion and marketing compliance, as well as facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified communication goals.
• Initiate and drive workflow optimization projects and implement technology optimization, and enforce the adherence of all copy and claims approvals to the defined standards. 
• Partner with cross-functional reviewers (e.g. Quality, Regulatory, Medical Affairs, Marketing, Healthcare Compliance, Legal, HE&R, Data Privacy, Communications, etc.) and manage non-conformance activities within the Ethicon Franchise Quality System. 

• A minimum of a Bachelor’s degree is required, preferably in a Scientific field. An Advanced degree (MS, PhD, MD, JD etc.) is preferred.
• A minimum of 7 years relevant experience in a regulated healthcare environment is required. 
• Experience in either medical devices, biologics and/or combination products is preferred
• Experience in one of the following: Advertising and Promotion, Regulatory Affairs and/or Healthcare Compliance is strongly preferred. 
• Working knowledge of regulatory promotional practice laws, regulations, policies, guidelines is preferred.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs
Requisition ID