Director Clinical Evaluation, Medical OperationsJohnson & Johnson Services, Inc. - Warsaw, IN
Director Clinical Evaluation, Medical Operations
J&J Family of Companies
Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Director Clinical Evaluation, Medical Operations to be located at any Johnson & Johnson Medical Device Company based in the United States. This position will require up to 30% domestic and international travel.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Director Clinical Evaluation will provide strategic oversight and governance ensuring high standards of compliance in Medical Operations functions charged with delivery of key regulatory and medical documents. You will lead a diverse Medical Operations team based in multiple geographies and ensure the identification and retention of high potential individuals through active engagement, motivation, development, and promotion. You will provide leadership and manage relationships through extensive interdependent partnering, benchmarking, leveraging of best practices, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. You will support the Medical Operations lead for the EU MDR project establishing the strategy surrounding CERs and SSCPs.
In this exciting role, you will:
Lead a team of medically competent scientists across OneMD to compile and analyze product related safety and performance data, draft reports and coordinate approval of Medical Affairs-generated Regulatory documents.
Be responsible for the effective optimization and harmonization of CER and SSCP processes within OneMD while aligning with the J&J Enterprise guidelines and regulatory requirements.
Ensure the CER and SSCP processes are linked to appropriate Quality Systems and Regulatory Processes to ensure information is accessible where needed and will develop, implement and manage an effective communication model for CERs/SSCPs
Provide management leadership to their staff to provide direction and to support the professional development of direct reports.
In addition, you will:
Design, develop and lead workshops to define processes globally and keeps abreast of regulatory requirements and industry trends / practices.
Develop and monitor metrics for CER & SSCPs across OneMD, providing visibility of issues and enable corrective and preventive action to be taken as needed.
Accountable to support the development and management of the Medical Operations budget pertaining to CERs/SSCPs across the OneMD businesses
Act as the Medical Operations liaison with respective Notified Bodies and regulatory agencies regarding CERs and SSCPs helping to shape JNJ OneMD strategies and building critical relationships.
Support and act as an SME during audits and inspections pertaining to OneMD CER processes
Partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR/Literature processes
A minimum of a Bachelorâ€™s Degree is required
A focused degree in Life Sciences, Engineering or related discipline is highly preferred
An advanced degree, MBA, PhD or MD is highly preferred.
A minimum 10 years of related experience is required
A minimum 3 years people/organizational leadership experience within a complex matrixed environment is required
Experience in Medical Device is highly preferred.
Experience in a highly compliant environment is required
Previous Clinical experience and knowledge of clinical trial design, evidence generation, adverse event reporting and surgical practices/principles is highly preferred
Demonstrated knowledge and experience in quality, regulatory and healthcare compliance is required.
Previous budgetary responsibility is preferred
Project Management/Six Sigma certifications highly preferred
Ability to translate insights into viable process and solutions that create value in Medical Operations is highly preferred
Demonstrated experience at an Enterprise level is required
Experience in culture development is also required
Ability to collaborate on a global level is required
Excellent communicator, can manage and lead change is required
Fluent in influencing leadership presence across the Matrix is also 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.
North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)
8 days 17 hours ago
applyDirector Clinical Evaluation, Medical Operations Johnson & Johnson Services, Inc. - Warsaw, IN, United States
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.
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