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Clinical Evaluation Project Manager
- J&J Family of Companies (Cincinnati, OH)
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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, Raritan, New Jersey, United States of America
Job Description:
Johnson & Johnson is recruiting for a **Clinical Evaluation Project Manager** to join our MedTech Surgery business.
This is a remote role available in multiple [states/cities]. 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 various locations to apply.
About Surgery
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
The Clinical Evaluation Project Manager acts as the project management process owner for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP) for Ethicon Endo Surgery within J&J MedTech in their scope of responsibility.
This role focuses on process optimization and the deployment and utilization of consistent project management methodologies supporting key planning and execution steps.
DUTIES & RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
+ Uses project management tools, such as WRIKE, and to monitor smooth and timely execution of project milestones and tasks for the Technical Writing team.
+ Ensures timelines are met and practices are being consistently deployed across the global organization.
+ Maintains knowledge and access to applicable J&J MedTech Quality Systems to support the team in document retrieval and routing of documents for approval.
+ Maintains and monitors metrics relevant to the assigned activities and communicates business related issues or opportunities to next management level to enable corrective and preventive action to be taken as needed.
+ Sets up and leads meetings for project execution per project plan, as well as meetings in support of the overall project management process.
+ Drives communication and establishes relationships with cross-functional business partners such as other Scientific Operations Team Members, Post Market Surveillance, Clinical, Medical Safety, Design Quality Engineers, R&D, and Regulatory Affairs.
+ Is responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
+ Performs other duties as assigned.
EXPERIENCE AND EDUCATION
+ Bachelors degree or equivalent experience in a technical field is required; advanced degree is preferred.
+ Minimum of 2 years of related job experience is required.
+ Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and state of the art and systematic literature review creation is preferred.
+ Experience in resource coordination with respect to processes and outcomes.
+ Experience with WRIKE or project management systems is preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
+ Demonstrated understanding and experience in project management principles and methodologies is required.
+ Strong written and oral communication skills is required.
+ Strong interpersonal skills to enable ongoing communication (face to face, phone and email) with team members and coordination of data collection is required.
Benefits Summary:
+ 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
+ Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below!
https://www.careers.jnj.com/employee-benefits
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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$89,000 - $143,750 (Bay Area: $103,000 - $165,600)
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.
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