Senior Specialist, Global Clinical Evaluation - MedTech Surgery

Johnson & Johnson Innovative Medicine • Cincinnati, OH

6d • $109,000 - $174,800 • Remote

About The Position

The Senior Specialist, Global Clinical Evaluation will serve as an operational excellence subject matter expert across systematic literature reviews, clinical data appraisal and analytics, and medical/technical writing, supporting key deliverables including clinical evaluation reports (CER), summaries of safety and clinical performance (SSCP), post-market surveillance reports (PMSR), periodic safety update reports (PSUR), new product development (NPD) evidence generation strategies, premarket approval (PMA) annual reports, and Health Authority requests for all therapeutic areas / operating companies / platforms within the J&J MedTech Surgery business unit. The Senior Specialist will translate strategy into execution by optimizing processes, standardizing tools/templates, and enabling scalable, efficient delivery models.

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
• Change management expertise required

Nice To Haves

• Experience with global medical device regulations and guidelines preferred
• 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

Responsibilities

• 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

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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior