Post Market Clinical Review Specialist

Johnson & Johnson • Cherry Hill, NJ

16d • 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 https://www.jnj.com Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America, Remote (US) Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech This is a remote role available in Danvers within Massachusetts. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for Post Market Clinical Review Specialist Job Description The Clinical Review Specialist will serve as clinical expert for the complaint intake review process. They will provide clinical rationale linking patient clinical presentation, procedural events, and product interaction. They will serve as a clinical resource for cross functional teams including engineering, quality, and innovation excellence. They will work under the supervision of the Associate Director, Post Market Clinical Review on ensuring coding and case review objectives are relevant, compliant and meet FDA standards.

Requirements

• Minimum of 5 years cardiology experience
• Demonstrate effective collaboration through previous partnerships and activities
• Must have a keen sense of prioritization, organization, flexibility, and time management to ensure maximum effectiveness for the benefit of the team.
• Able to maintain confidentiality, establish secure filing procedures and safeguard materials and information required
• Possess executive communication skills
• Demonstrates high level of professionalism
• Ability to influence cross functional teams in a constructive manner
• Proficiency in medical writing skills
• Proficiency with Microsoft office programs required

Nice To Haves

• Preferred complete Abiomed product portfolio experience

Responsibilities

• Collaborate with the post market complaint operations and regulatory review teams to ensure coding guidelines are adhered to
• Review complaint intakes for coding accuracy and provide written narratives to meet FDA standards
• Collaborate with the Medical Safety Office and Medical Office to provide updated guidelines to the Coding Guide
• Provide clinical support for post market customer outreach
• Provide clinical support for post market engineering as needed
• Collaborate with cross functional teams to provide field team education regarding the complaint handling process
• Support research teams in efficiently and compliantly reporting complaints

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits: o Vacation – up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed