Job Description

DePuy Synthes is recruiting for a Senior Manager, Clinical Evaluations, Medical Operations; primarily based in West Chester, PA but remote may be acceptable in the United States.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

This role is responsible for leading all aspects of Clinical Evaluation Report (CER) and Summary of Safety and Clinical Performance (SSCP) Report generation for the DePuy Synthes Trauma, Craniomaxillofacial, and Biomaterials franchises.

Key Responsibilities:

* Provides managerial leadership to team preparing CERs/SSCPs
* Provides strategic oversight and mentorship to all resources on document execution and generation
* Manages relationships and contracting with external vendors for generation of documents supporting these processes
* Develops strategic plans to ensure CER/SSCP timelines are met and recommended practices are being consistently deployed across the global organization
* In conjunction with the Director; designs, develops and leads workshops to define processes globally and stays on top of regulatory requirements and industry trends / practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
* Develops and tracks metrics for CERs/SSCPs within his/her therapeutic space, providing transparency of issues to enable corrective and preventive action to be taken as needed
* Accountable for assisting in the development and management of the Medical Operations budget pertaining to the businesses within his/her scope of responsibility
* Supports interactions with respective Notified Bodies and regulatory agencies regarding CERs/SSCPs
* Supports audits and inspections pertaining to CER/SSCP processes and reports.
* Actively partners with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSCP process

Qualifications
* A Bachelor's degree, BA, BS, or BSN is required; advanced degree is preferred
* Minimum of 5 or more years of related job experience is required, with at least 2 years of experience writing and/or editing clinical evaluation reports associated with MDD or MDR is required.
* Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation is required.
* Able to understand and interpret statistical results of clinical studies and understands good data management practices is required
* Strong verbal communication, presentation, project management and prioritization skills is required
* Excellent interpersonal relationships is required
* Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred.
* Travel percentage - 10 percent or less

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.

LI-JBROWN52

Primary Location
United States-Pennsylvania-West Chester-1230 Wilson Drive
Other Locations
North America-United States
Organization
Medical Device Business Services, Inc (6029)
Job Function
R&D;
Requisition ID
2105908554W