Note: The job is a remote job and is open to candidates in USA. Vita Global Sciences, a Kelly company, provides functional service provider support for its medical device client. The Senior Technical Writer oversees and executes Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance Reports (SSCPs), ensuring accuracy, regulatory compliance, timely delivery, and process improvement.
Responsibilities
- Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporation's procedures and guidelines, this position is responsible for: Planning and writing CERs and SSCPs and mentoring junior technical writers
- Conducting technical reviews to ensure document accuracy and compliance to local procedures, guidelines and regulatory requirements
- Partnering with team members to address needs of each contributor
- Managing daily activities to ensure timelines are met
- Participating in workshops and other initiatives to help define and continuously improve process efficiency
- Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices
- Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports
- Responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Skills
- •BA, BS, or BSN is required
- • Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation
- • Strong verbal communication skills and interpersonal relationships
- Advanced degree is preferred
- • Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred
Benefits
- Remote work opportunity
- Medical benefits
- Dental benefits
- Vision benefits
- 401(k)
- Paid time off, including holiday, vacation, and sick/personal time
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