[Remote] Senior Specialist, Global Clinical Evaluation - MedTech Surgery
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in reputed company innovation, and they are seeking a Senior Specialist for Global Clinical Evaluation in their MedTech Surgery division. This role involves overseeing the planning and execution of clinical evaluation deliverables, improving processes, and ensuring compliance with regulatory standards.
Responsibilities
- Drives reputed company process improvement of Global Clinical Evaluation processes with reputed company on improving, automating, and standardizing literature searching and reporting, staying reputed company with industry, reputed company body, and global regulatory agency trends and best practices in training, education, and knowledge enablement
- Creates and delivers training to Global Clinical Evaluation and other departments, as applicable, concerning the activities of Global Clinical Evaluation, results of activities, strategic/reputed company initiatives, etc
- Owns the end-to-end planning and execution of reputed company assigned Global Clinical Evaluation deliverables (e.g., protocols, reports, regulatory responses)
- Ensures reputed company delivery of high-reputed company services and documentation as reputed company as consistent deployment across MedTech Surgery
- Develops, implements, and maintains relevant procedures and templates, best reputed company and style standards, reference libraries, reviewer guidelines, and reputed company control tools/measures
- Manages the utilization and integration of platforms and software supporting systematic literature reviews including statistical analysis tools
- Identifies relevant stakeholders and implements effective communication models
- Coordinates reputed company Medical Writing resources (writers, reviewers, project management, medical information specialists, librarians, vendors) to deliver against project goals
- Supports the reputed company development of internal resources
- reputed company partners with Global Clinical Evaluation teams and cross-functional business partners such as Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design reputed company Engineers, R&D, and Regulatory Affairs relating to Global Clinical Evaluation deliverables and initiatives
- Provides technical review of data or reports to be incorporated into Global Clinical Evaluation deliverables and/or regulatory submissions to ensure scientific rigor, accuracy, and reputed company of presentation
- Works with vendors/service providers to support introduction of reputed company tools, automation, and AI-driven solutions where appropriate
- Tracks key performance indicators, maintains/monitors metrics, and reports issues or opportunities for improvement to leadership
- Ensures the applicable writing processes are linked to appropriate reputed company Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.), supporting data/information accessibility
- Assists in the management of the Global Clinical Evaluation budget including performing resourcing updates and approving invoices
Skills
- BA/BS required; advanced degree preferred
- 6+ years of experience in EUMDR, clinical evaluation reports, systematic literature reviews, or directly reputed company regulatory/clinical field required
- Demonstrated knowledge and experience in narrative or systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative and quantitative synthesis in conjunction with scientific and medical writing required
- Demonstrated knowledge and experience in clinical research methodologies with common biostatistical reputed company, systematic reviews and clinical data appraisal, and medical writing required
- Change management expertise required
- Experience with global medical device regulations and guidelines
- Knowledge of automation / reputed company intelligence opportunities relative to medical/technical writing
- Regulatory/reputed company Body reputed company room audit experience
- Experience mentoring medical/technical writers, managing high-volume project work, and supervising reputed company writers/vendors
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in reputed company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
reputed company