Principal Clinical Safety Specialist - Shockwave Reducer

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 https://www.jnj.com

Job Function:
Product Safety

Job Sub Function:
Drug & Product Safety Operations

Job Category:
Professional

All Job Posting Locations:
New Brighton, Minnesota, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal Clinical Safety Specialist– Shockwave Reducer to join our team located in New Brighton, MN.

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 https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Principal Clinical Safety Specialist will have primary responsibility for study or program oversight, ensuring all aspects of safety are conducted according to procedure and in a compliant manner.

The Principal Clinical Safety Specialist may oversee one or more studies, assuming ownership for study-specific requirements.

This may include special projects, process development, vendor oversight, audit participation, and providing advisory to the clinical and post-market surveillance teams.

In addition, the Principal Clinical Safety Specialist will be responsible for providing backup support for adverse event collection and processing, safety monitoring, maintenance of study-specific Safety Management Plans, and participation in writing and/or reviewing safety sections of clinical study documents.

This may also include management of Clinical Events Committee(s) and Data Safety Monitoring Board(s).

Esse...