Manager, Medical Writing, Clinical & Regulatory Affairs

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:
Medical Affairs Group

Job Sub Function:
Medical Writing

Job Category:
Professional

All Job Posting Locations:
Danvers, Massachusetts, United States of America, Remote (US)

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, Medical Writing, Clinical & Regulatory Affairs.

This is a remote role available in the continental USA.

Purpose: The Manager, Medical Writing, Clinical & Regulatory Affairs will lead & support the development of regulatory documents and processes, with a focus on EU post-market surveillance requirements to drive better patient outcomes with the use of Abiomed products.

The Manager, Medical Writing will oversee post-market surveillance activities within the Clinical and Regulatory Affairs department.

The ideal candidate will be able to directly influence and maintain an ongoing, systematic, and controlled process to maintain compliance with appropriate regulations for Abiomed products.

You will be responsible for:


* Plan, prepare, and finalize regulatory documents focused on global post-market surveillance requirements, particularly US and EU; these include, but are not limited to, clinical evaluation plans and reports, post-market surveillance plans, summary of safety and clinical performance (SSCP), and post-market clinical follow-up plans and reports (PMCF) 



* Support establishment and execution of document timelines and strategies for sustaining efficient, ongoing processes to maintain compliance with EU regulatory requirements 



* Conduct literature reviews and clinical data reviews to support preparation of regulatory documents and submissions 



* Support cross-functional document planning and review through collaboration with colleagues across departments ...