Senior Specialist, Global Clinical Evaluation – MedTech Surgery

Johnson & Johnson

Senior Specialist managing global clinical evaluation processes for Johnson & Johnson MedTech Surgery. Focused on operational excellence in clinical data and regulatory submissions.

Posted 7/16/2026full-timeRemote • New Jersey, Ohio • 🇺🇸 United StatesSenior💰 $109,000 - $174,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Global Clinical Evaluation processes, including systematic literature reviews, regulatory compliance, and medical writing. Proficient in managing cross-functional teams and delivering high-quality documentation while leveraging automation and AI-driven solutions.

Highest-signal resume keywords

EUMDRSystematic Literature ReviewsClinical Evaluation ReportsChange Management ExpertiseMedical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research MethodologiesBiostatistical MethodsQualitative and Quantitative SynthesisRegulatory ComplianceData Appraisal

Soft Skills

Effective CommunicationMentoringProject Management

Tools & Technologies

Statistical Analysis ToolsAutomation SolutionsAI-Driven Solutions

Industry Keywords

Global Medical Device RegulationsQuality SystemsRegulatory ProcessesRisk ManagementNotified Body Audit Experience

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Comp & perks

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