Requisition ID: 5827170814
Johnson & Johnson Medical Devices , a member of Johnson & Johnson's Family of Companies, is recruiting for a Technical Writer with primary location in Somerville, NJ other locations in Warsaw, IN; Raynham, MA; Irvine, CA; Cincinnati, OH or field based will be considered. This position may require up to 10% 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 7years. 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 Technical Writer, Shared Services acts as a team member supporting and executing the Clinical Evaluation Report and Safety Surveillance Report processes for the assigned therapeutic areas within the Ethicon businesses. You will support and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports. You will ensure the CER and SSR 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. You will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners. The Technical Writer will:
- Actively 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 process
- Be responsible for the writing of Clinical Evaluation Plans
- Participate 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.
- Be responsible for compliant writing of Clinical EvaluationReports within this business in accordance to local procedures, J&J guidelines and regulatory requirements
- Assist in the development of schedules to ensure operating company CER/SSR timelines are met
- Ensure compliant creation of SSR reports within this business in accordance to local procedures, J&J guidelines and regulatory requirements.
- A minimum of a Bachelor’s Degree is required
- Master’s or advanced degree is preferred
- A minimum of 3years’ relevant job experience is required
- Experience in related industry is also required
- Knowledge of clinical evaluationreport regulatory requirements, evidence generation, and CER document creation is required.
- Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse eventreporting, medical device risk management processes, and experience with common bio statistical methods is preferred
- Regulatory/Notified Body auditexperience is preferred