Senior Specialist, Global Clinical Evaluation - MedTech Surgery

Johnson & Johnson•Cincinnati, NJ

1d•Remote

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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