Senior Specialist, Global Clinical Evaluation - MedTech Surgery

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.

Job Function:

R&D Operations

Job Sub Function:

Clinical/Medical Operations

Job Category:

People Leader

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America

Job Description:

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

We are searching for the best talent for Senior Specialist, Global Clinical Evaluation

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.

You will be responsible for:

Under limited supervision of the Director, Global Clinical Evaluation and in accordance with all applicable regulations, procedures, and guidelines, the Senior Specialist:

• 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