Director, Regulatory Advertising & Promotion

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Director, Regulatory Advertising & Promotion to be based in Horsham, PA. The primary location will be Horsham, PA with the option to work from a secondary location (Titusville, NJ; Raritan, NJ; or New Brunswick, NJ) once a week.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine.

You will be responsible for:

• 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.