Leads end to end project management activities including project plan development, dashboard generation, metrics tracking, risk identification and mitigations, resource planning, and development of communication strategies.
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.
Manage maintenance and updates to key SciOps systems, including Wrike, Distiller, Readcube, Sharepoint, etc.
Leads (in collaboration with the Director of Scientific Operations) regular business cycle activities including management of statements of work, purchase orders, invoicing, accruals, business planning, and vendor management.
Provides change management expertise to support procedural and workflow changes.
Defines, maintains, and monitors metrics relevant to the Global Clinical Evaluation team’s activities and adjacent teams/functions, providing real-time progress tracking and visibility of issues to enable corrective and preventive action to be taken, as needed.
Oversees Eudamed maintenance for SciOps specific activities, including SSCP translation uploads and SSCP Validation by the notified bodies.
Responsible for communicating business related issues or opportunities to next management level.
Is responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Performs other duties as assigned.
Requirements
Bachelors degree or equivalent experience in a technical field is required; advanced degree is preferred.
Minimum of 7 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.
Proficiency in Microsoft Applications (Word, Excel, Outlook, Teams, and PowerPoint) and Adobe Acrobat.
Proficiency with project management methodologies and project planning tools such as Wrike, MS Project, or Smartsheet.
Exceptional communication and social skills across different organization levels.
Excellent analytical, problem-solving, and decision-making abilities.
Process Excellence training or certification preferred.
Project Management Professional (PMP) certification preferred.
Tech Stack
PMP
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year