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/Medical Operations

Job Category:

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Irvine, California, United States of America, New Brunswick, New Jersey, United States of America, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, San Jose, California, United States of America, Warsaw, Indiana, United States of America

Job Description:

We are searching for the best talent for a Manager, Global Clinical Evaluation to join our MedTech Surgery Team. This is a remote position based in the United States.

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

Purpose:
The Manager, Global Clinical Evaluation provides leadership, motivation, and strategic direction for the general technical writing activities for the generation of Clinical Evaluation Reports/Plans (CER) and Summary of Safety and Clinical Performance Reports (SSCP) for their assigned therapeutic area within J& J MedTech Surgery. They also support broader initiatives and cross-platform activities to support the continuous process improvement activities of the Global Clinical Evaluation Team.

You will be responsible for:

• Provides oversight and guidance to resources on compliant document execution and generation
• Manages relationships and contracting with external vendors for generation of documents supporting these processes
• Develops strategic plans to ensure operating company deliverable timelines are met, and practices are being consistently deployed across the global organization
• In conjunction with the leadership team, designs, develops and leads workshops to define processes globally and keeps abreast of regulatory requirements and industry trends / practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
• Develops and monitors metrics for progress and results within the assigned therapeutic space, providing visibility of issues and enable corrective and preventive action to be taken as needed
• Accountable for assisting in the development and management of the Global Clinical Evaluation Team budget pertaining to the businesses within the assigned scope of responsibility
• Supports interactions with respective Notified Bodies and regulatory agencies regarding deliverables in scope
• Supports audits and inspections pertaining to CER/SSCP processes and reports
• Actively partners with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R& D, and Regulatory Affairs relating to the CER/SSCP process
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications:

• Minimum of a Bachelor’s Degree required, Advanced Degree strongly preferred; Life Sciences background desired
• At least 5 years of related professional experience within the medical device required
• Knowledge of EU regulatory requirements, clinical evidence generation, and CER creation required
• Demonstrated knowledge and experience in quality, regulatory, and healthcare compliance required
• People/organizational leadership experience within a complex cross-functional environment preferred
• Knowledge of clinical study design, adverse event reporting, statistical analysis and interpretation, and surgical practices/principles preferred
• Regulatory/Notified Body audit experience preferred

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

#LI-Rmote

The anticipated base pay range for this position is:

$115, 000-$195, 000. California Bay Area- $139, 000-$220, 000

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 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)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year 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 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 Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.