Director, UDI Program and Data Strategy
Director, UDI Program and Data Strategy - 2406171162WDescriptionJohnson and Johnson Med Tech is now recruiting for a Director, UDI/GSI Program and Data Strategy Leader to be located in Raynham, MA or Raritan, NJ.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/.We are seeking an experienced and dynamic individual to lead the deployment of the Unique Device Identification (UDI) program and Data Strategy. As the Director for UDI/GS1 Program & Data Strategy, you will play a pivotal role in ensuring our business compliance with GS1, GUDID, EUDAMED, and upcoming regulatory requirements related to UDI. This strategic position encompasses ownership of the overall strategy, program, and project deployment, including performance management, processes, governance, and the development of both manual, hybrid, and automated solutions to facilitate the seamless flow of required data and documentation to external governing bodies. This leader will play a key role in defining and shaping the MedTech label/UDI data model.
An Internal candidate has been identified. All applications will be considered.
Key Responsibilities:
UDI Program Ownership & Communications:
Develop and own the comprehensive strategy for UDI program compliance.
Lead the end-to-end deployment of UDI initiatives, ensuring alignment with GS1, GUDID, EUDAMED, and future regulatory requirements.
Oversee program and project deployment, ensuring adherence to timelines and milestones.
Ensure comprehensive and timely program and progress communications.
Compliance Management:
Establish and manage performance metrics to ensure ongoing compliance with regulatory standards.
Implement robust processes and governance structures to guarantee adherence to UDI program requirements.
Stay abreast of evolving regulatory requirements and proactively address compliance challenges.
Data Flow Solutions:
Develop innovative and efficient manual, hybrid, and automated solutions for the seamless flow of required data to external governing bodies.
Collaborate with cross-functional teams to implement data management solutions that meet compliance standards.
Stakeholder Collaboration:
Collaborate closely with business franchises to understand their unique needs and ensure the success of the UDI program deployment.
Establish effective communication channels and feedback mechanisms with key stakeholders to drive program success.
Process Optimization:
Continuously evaluate and optimize UDI-related processes and procedures to enhance efficiency and effectiveness.
Implement best practices and industry standards to drive excellence in UDI program management.
Data Strategy:
Defines and develops the data strategy for labeling, IFU and UDI required data
Collaborates with cross functional teams to establish key data use cases and deployment roadmaps in alignment with MedTech data strategy
Direct reports:
Directly manages a team of 5-7 staff
Qualifications
10 plus years of relevant Supply Chain, Quality, Regulatory or R&D experience
Bachelor's degree in a relevant field; advanced degree preferred.
Proven track record of successful leadership in strategic, complex and global deployment of supply chain capabilities or related fields.
Strong understanding of GS1, GUDID, EUDAMED, and other data publishing applications such as UDI.
Experience in deploying UDI programs and ensuring compliance with regulatory and quality standards is preferred.
Demonstrated ability to develop and implement data flow solutions, including manual, hybrid, and automated approaches.
Strong grasp of MedTech’s data landscape from R&D to regions
Must possess excellent communication, interpersonal, and collaboration skills.
Proven capability to mastering complexity and making the complex simple.
Strategic mindset with the ability to align UDI and data initiatives with overall business goals.
Other:
This position will require up to 10% travel.
The anticipated base pay range for this position is $142,000 to $244,950.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.For additional general information on Company benefits, please go to:
https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on March 11, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Primary Location NA-US-Massachusetts-RaynhamOther Locations NA-US-New Jersey-RaritanOrganization Medical Devices & Diagnostics Global Services, LLC (6209)Job Function Product StrategyReq ID: 2406171162W