Project Manager Medtech Neurovascular

Johnson & Johnson Innovative MedicineIrvine, CA
Hybrid

About The Position

Johnson & Johnson is recruiting for a Project Manager, Medtech Neurovascular to join our team in either Irvine, CA or Raritan, NJ. 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. The Project Manager reporting to the Associate Director of Scientific Operations within the Clinical Research & Data Science team, will lead strategic oversight and process governance for project management activities associated with essential medical and regulatory documentation for J&J MedTech Neurovascular, including Clinical Evaluations, Literature Reviews, and Periodic Safety Update Reports. This individual will identify, plan, and implement process improvement initiatives that promote agility and efficiency across the team’s cross-functional collaborations and responsibilities. The Project Manager will focus on real-time progress toward key business goals and objectives and effective communication among team members as well as senior leadership.

Requirements

  • Bachelors degree or equivalent experience in a technical field is required
  • Minimum of 7 years of related job experience is required
  • 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.

Nice To Haves

  • advanced degree is preferred
  • 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.
  • Process Excellence training or certification preferred.
  • Project Management Professional (PMP) certification preferred.

Responsibilities

  • 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.

Benefits

  • 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
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