DePuy Synthes is recruiting for a Senior Technical Writer, Medical Operations, located in Warsaw, IN! Remote work options may be considered on a case by case basis if approved by the company.
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.
- Responsible for the technical review ensuring the accuracy and compliance of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance (SSCP) documents
- Responsible for compliant writing of Clinical Evaluation Reports and Plans within this business in accordance to local procedures, J&J guidelines and regulatory requirements
- Responsible for ensuring compliant creation of SSCP documents within this business in accordance to local procedures, J&J guidelines and regulatory requirements
- Ensures the CER and SSCP files are linked to appropriate Quality Systems and Regulatory documents (e.g., Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. They will develop, implement, and manage an effective communication model for CERs/SSCPs with cross functional business partners
- Assists in the development of schedules to ensure operating company CER/SSCP timelines are met
- Participates in workshops and on initiatives to help define processes globally and keep abreast of CER 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
- Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports