3 months ago
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a a Senior Director, Global Strategy and Advertising/Promotion to be preferably located in Somerville, NJ, Cincinnati, OH or United Kingdom, England.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to led the industry today along with innovative energy devices for surgery.
Global Strategy and Franchise:
* Responsible for leading a team which supports innovation, life-cycle, and compliance activities across the Ethicon franchise (Wound Closure & Repair, Endo-mechanical, Energy, Biosurgery, Interventional Solutions, and Digital Surgery) with a focus on key strategic markets outside the U.S. and E.U., including China, Japan, Russia, and Brazil.
* Partner with Ethicon platform leaders and Regional leaders to set strategic direction and priorities for registration and product launch.
* Monitor complex issues related to the maintenance of global product registrations in strategic markets, and, when necessary, develops and leads remediation activities.
* Identify and implement streamlined regulatory processes and direct the team to deliver robust regulatory strategies required to obtain and sustain market access in focus markets.
* Partner with Regulatory Policy team to monitor changes in regulations and expectations in key strategic markets and shape future regulatory changes.
* Optimize Regulatory resources and drive operational efficiency across Ethicon by ensuring a harmonized approach across the Ethicon Regulatory platforms and taking ownership of centralized responsibilities, including but not limited to Ethicon Standards Management, Product Issue Escalations, International Change Assessments, and Supply Chain initiatives.
* Lead, build, and develop a team of Regulatory professionals across multiple locations to ensure strong talent pipeline within Global Strategy and Advertising & Promotion.
* Build strong and trusting relationship with Regulatory leaders in the other Franchises, RALI, Policy, and Regions and cross-functional leaders in Supply chain and Commercial and be recognized as a trusted voice of the Ethicon franchise.
* Member of the Ethicon Regulatory Affairs Leadership Team, Regional Regulatory leadership teams, Standards Management, and as delegate for various Ethicon Quality Councils, Management Review, CAPA Reviews, Data Review Boards, and Quality Review Boards.
* Oversee collection and reporting of Ethicon Regulatory metrics for submission, approval, and launches.
* Primary Franchise contact for Key sector communications (OneMD Regulatory Affairs COE Newsletter, Sharepoint site, etc.).
* Support the development and monitoring of the organizational budget
* Provide strategic oversight of Regulatory advertising & promotion compliance activities for Ethicon products, including strategies for procedural based marketing, digital surgery, and the inclusion of Important Safety Information (ISI) into marketing materials.
* Lead the team that conducts regulatory promotional labeling and marketing compliance reviews to ensure that materials and communications are consistent with product labeling, are adequately supported, and are in compliance with applicable laws, regulations and policies related to advertising & promotion of medical devices, biologic and combination products.
* Ensure promotional labeling and marketing materials are reviewed in a timely manner consistent with internal metrics and that the reviews conducted across the Ethicon franchise are performed in a consistent manner.
* Ensure marketing and promotional claims used in Europe are in compliance with European Medical Device Regulation requirements and have sufficient substantiating evidence on file.
* A minimum of a Bachelor's Degree required. An Advanced degree is preferred.
* A minimum of twelve (12) years of experience within a regulated industry required, with minimum of five (5) years of experience in medical devices preferred
* A minimum of five (5) years of experience leading teams is required, preferably in a virtual environment.
* Broad experience in Regulatory Affairs required
* Working knowledge and thorough understanding of how global regulations impact current product registrations required.
* Approximately 25% travel, domestic/international may be required
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.
United States-New Jersey-Somerville
Europe/Middle East/Africa-United Kingdom-England, United States-Ohio-Cincinnati
Depuy Orthopaedics. Inc. (6029)