Manager, Global Clinical Compliance

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:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Alabama (Any City), Alabama (Any City), Arizona (Any City), Arkansas (Any City), California (Any City), Colorado Springs, Colorado, United States of America, Connecticut (Any City), Danvers, Massachusetts, United States of America, Delaware (Any City), Florida (Any City), Georgia (Any City), Idaho (Any City), Illinois (Any City), Indiana (Any City), Iowa (Any City), Kansas (Any City), Kentucky (Any City), Louisiana (Any City), Maine (Any City), Maryland (Any City), Michigan (Any City), Minnesota (Any City), Mississippi (Any City), Missouri (Any City), Montana (Any City) {+ 23 more}

Job Description:

About Cardiovascular

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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke.

You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

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 a Manager, Global Clinical Compliance.  This is a remote role available in the continental USA.
 

Purpose: The Manager, Global Clinical Compliance is responsible for ensuring that clinical studies are executed in accordance with applicable international, federal, and local regulations, Good Clinical Practices (GCP), and Abiomed internal Standard Operating Procedures (SOPs).

She/he will serve as a resource for clinical study teams to instill regulation awareness and promote a constant state of inspection readiness, inclusive of identifying potential risks and advising on solutions to ensure high quality clinical evidence is generated in support of clinical study tactical plan objectives.

She/he will conduct routine quality checks of clinical studies to ensure that quality records are accurate, complete, and contemporaneous.

She/he will take an ownership role of the Clinical Quality System, ensuring alignment with regulations, GCP, and corporate quality standards; levera...