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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.

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.

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.