Clinical Evaluation Project Manager

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:

Raritan, New Jersey, United States of America

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
 

Remote work options may be considered on a case-by-case basis and if approved by the Company

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
 

We are searching for the best talent for Clinical Evaluation Project Manager to be in Raritan, New Jersey.

JOB SUMMARY

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.

Additional Information:

· The expected base pay range for this position is $89,00 to $143,000 / annually.
· The Company maintains highly competitive, performance-based compensation programs. Und