Manager Clinical Evaluation Jobs (NOW HIRING)

Overview We are searching for a Senior Specialist, Global Clinical Evaluation to serve as an operational excellence subject matter expert across systematic literature reviews, clinical data appraisal, and medical/technical writing. The role supports 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, PMA annual reports, and Health Authority requests across all therapeutic areas within the MedTech Surgery business unit. Responsibilities Drive continuous process improvement of Global Clinical Evaluation processes, focusing on automated, standardized literature searching and reporting. Create and deliver training for Global Clinical Evaluation and other departments on activities, results, and strategic initiatives. Own end‐to‐end planning and execution of assigned global clinical evaluation deliverables such as protocols, reports, and regulatory responses. Develop, implement, and maintain procedures, templates, best‐practice style standards, reference libraries, reviewer guidelines, and quality‐control tools. Manage utilization and integration of platforms and software supporting systematic literature reviews and statistical analysis tools. Identify stakeholders and implement effective communication models. Coordinate internal and external medical writing resources (writers, reviewers, project managers, medical information specialists, librarians, vendors) to meet project goals. Support the professional development of internal resources. Partner with cross‐functional teams such as Medical Directors, Medical Safety, Post‐Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs on deliverables and initiatives. Provide technical review of data or reports for incorporation into deliverables and regulatory submissions to ensure scientific rigor and clarity. Work with vendors and service providers to introduce scalable tools, automation, and AI‐driven solutions where appropriate. Track key performance indicators, monitor metrics, and report opportunities for improvement to leadership. Ensure writing processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS). Assist in managing the Global Clinical Evaluation budget, including resourcing updates and invoice approvals. Qualifications BA/BS required; advanced degree preferred. 6+ years of experience in EUMDR, clinical evaluation reports, systematic literature reviews, or a directly related regulatory/clinical field. Demonstrated knowledge of narrative or systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative and quantitative synthesis. Experience in clinical research methodologies, common biostatistical methods, and medical writing. Experience with global medical device regulations and guidelines preferred. Change‐management expertise required. Knowledge of automation or AI opportunities related to medical/technical writing preferred. Regulatory/Notified Body front‐room audit experience preferred. Experience mentoring medical/technical writers, managing high‐volume projects, and supervising internal and external writers/vendors preferred. Required Skills Analytical Reasoning Clinical Operations Clinical Research and Regulations Clinical Trial Design Communication Developing Others Ethical and Participant Safety Considerations Good Clinical Practice (GCP) Inclusive Leadership Innovation Laboratory Operations Leadership Operational Excellence Process Oriented Research and Development Study Management Team Management Compensation and Benefits Base pay range: $109,000.00 – $174,800.00 Eligibility to participate in the Company's consolidated retirement plan and 401(k). Long‐term incentive program eligibility. Vacation: 120 hours per calendar year Sick time: 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington) 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 child birth/adoption/foster care Bereavement leave: 240 hours (40 hours for 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 EEO & Accessibility Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities. If you are an individual with a disability and would like to request an accommodation, please contact us via our careers site or through AskGS for an accommodation resource. #J-18808-Ljbffr