Senior Specialist, Global Clinical Evaluation – MedTech Surgery
Location
New Jersey + 1 moreAll locations: New Jersey | Ohio
Posted
47 days ago
Salary
$109K - $174.8K / year
Seniority
Senior
Job Description
Senior Specialist, Global Clinical Evaluation – MedTech Surgery
Johnson & Johnson
• Drives continuous process improvement of Global Clinical Evaluation processes with focus on improving, automating, and standardizing literature searching and reporting, staying current with industry, notified 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/quality initiatives, etc. • Owns the end-to-end planning and execution of all assigned Global Clinical Evaluation deliverables (e.g., protocols, reports, regulatory responses) • Ensures timely delivery of high-quality services and documentation as well as consistent deployment across MedTech Surgery • Develops, implements, and maintains relevant procedures and templates, best practice and style standards, reference libraries, reviewer guidelines, and quality 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 internal and external Medical Writing resources (writers, reviewers, project management, medical information specialists, librarians, vendors) to deliver against project goals • Supports the professional development of internal resources • Actively partners with Global Clinical Evaluation teams and cross-functional business partners such as Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality 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 clarity of presentation • Works with vendors/service providers to support introduction of scalable 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 Quality 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
Job Requirements
- BA/BS required; advanced degree preferred
- 6+ years of experience in EUMDR, clinical evaluation reports, systematic literature reviews, or directly related 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 methods, systematic reviews and clinical data appraisal, and medical writing required
- Experience with global medical device regulations and guidelines preferred
- Change management expertise required
- Knowledge of automation / artificial intelligence opportunities relative to medical/technical writing preferred
- Regulatory/Notified Body front room audit experience preferred
- Experience mentoring medical/technical writers, managing high-volume project work, and supervising internal and external writers/vendors preferred
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –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 within 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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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