Johnson & Johnson Careers

Manager, Regulatory Affairs, Advertising & Promotional Review

Cincinnati, Ohio; Norderstedt, Germany; Berkshire, United Kingdom; Dülmen, Germany; Livingston, United Kingdom; Somerville, New Jersey; Cincinnati, Ohio
Regulatory Affairs


Job Description

Requisition ID: 00001EAU

Ethicon Companies of Johnson & Johnson is recruiting for a Manager, Regulatory Affairs, Advertising & Promotional Review, located any of the following US locations (Cincinnati OH, Somerville NJ or OUS locations (Livingston UK, Berkshire UK, Norderstedt DE, Dulmen DE).
Ethicon US, LLC, a division of Johnson & Johnson, is a trusted world-wide leader in surgical care. We offer a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars, and hemostats devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Ad Promo is a member of the Global Strategy and Ad Promo Regulatory Affairs team. S/he is responsible for harmonizing the advertising and promotion regulatory compliance activities for the Ethicon Franchise, as well as defining and implementing process improvements to support advertising and promotional plans and ensure adherence to compliance targets and efficiency.
Overall responsibilities:
The Manager RA , Ad/Promo, is responsible for:
• Harmonizing the advertising and promotion regulatory activities for the Ethicon Franchise.
• Leading responses, developing and providing input for policies, procedures and training related to advertising and promotion.
• Defining and implementing process improvements to support advertising and promotional plans and ensuring adherence to compliance targets and efficiency.
Position duties & responsibilities:
• Interprets local and global regulations to ensure that products, processes, practices and procedures are in compliance with quality standards.
• You will closely collaborate with franchise RA to identify creative solutions and influence evidence generation strategies and establishes regulatory strategies that enable compliant promotional activities (e.g., Surgical Procedure Analysis [SPA] or procedural kit selling).
• Ensures compliance under applicable laws, regulations, guidelines and company policies by strategically supporting the franchise and addressing problems/opportunities by generating creative alternatives to achieve desired outcomes.
• Maintains up to date knowledge of regulatory requirements and

Qualifications
Qualifications:
• Bachelor’s degree is required, a degree in a health science or related field is preferable,
• An advanced degree is preferred
• A minimum of 8+ years of regulatory related experience in a regulated environment (e.g., medical devices, pharmaceuticals) is required.
• Working knowledge of U.S. and EU regulatory promotional practice laws is required.
• Knowledge of ad promo policies, guidelines and enforcement trends in medical device industry is preferred
• Knowledge of ad promo policies, guidelines and enforcement trends in biologic or combination products (drug & device), is preferred
• Understanding of global (beyond US & EU) ad promo regulations is preferred,
• Experience with evaluating clinical data and health economic data is preferred.
• An ability to manage a flexible schedule in consideration of U.S. based affiliates/stakeholders is required.
• May require up to 10% travel
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.


Primary Location
United States-Ohio-Cincinnati-
Other Locations
Germany-Schleswig Holstein-Norderstedt, Europe/Middle East/Africa-United Kingdom-England-Berkshire, Europe/Middle East/Africa-Germany-North Rhine Westphalia-Dülmen, Europe/Middle East/Africa-United Kingdom-Scotland-Livingston, United States-New Jersey-Somerville, United States-Ohio-Cincinnati
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
Regulatory Affairs
Requisition ID
00001EAU