Sr Regulatory Affairs Specialist (Advertising and Promotion, Global) - Shockwave Medical

Johnson & Johnson is hiring for a Senior Regulatory Affairs Specialist (Advertising and Promotion, Global) - Shockwave Medical to join our team.

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.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Senior Regulatory Affairs Specialist (Advertising and Promotion, Global) assisting with Advertising and Promotion Regulatory responsibilities, works closely and partners with internal departments to help efficiently and effectively meet assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to assist in ensuring that advertising and promotion activities meet regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist (Advertising/Promotion) is responsible for reviewing and approving advertising and promotional material in compliance with internal policies and applicable government laws and regulations. This individual will support decision-making on advertising and promotion regulatory activities.

Essential Job Functions

• Collaboratively interface with Global marketing/sales personnel, other cross-functional departments and external entities, as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with commercial approvals and within established timelines.
• Research and help maintain advertising and promotion regulatory policies, processes, SOPs & business aids and assist in training key internal stakeholders.
• In collaboration with Regulatory leadership and marketing personnel, help with establishing and maintaining product claims matrices for reference.
• Conduct global Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives. Approve advertising and promotional materials to ensure compliance.
• Collaborate with internal Regulatory stakeholders to help ensure that changes in product labeling are appropriately reflected in promotions and advertising.
• Work collaboratively with the commercial team and associated compliance functions to help ensure that approved materials are used within the intended guidelines and duration of use.
• Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and assist in developing/implementing corrective action plans for resolution of problematic issues with guidance from Regulatory leadership.
• Identify and communicate any emerging issues to Regulatory leadership and suggest solutions.
• Plan and conduct meetings, create project plans and timelines, and manage Advertising and Promotion related Regulatory projects with guidance from Regulatory Leadership.
• Exercise good and ethical judgment within policy and regulations.
• Other duties as assigned.