Labeling Project Coordinator / Project Coordinator (Pharma /Medical Device)

Windchill change management experience would be needed

purpose:

• Labeling workstream project manager responsible for the creation, coordination, approval and release of labeling.

Main Responsibilities:

• Communicate and implement an operational plan for completing the project.
• Creation of label requests, change orders, and monitoring the timeline from designer assignment until release.
• Work with Regulatory and Labeling team on Addendum Labeling readiness by product/country.
• Maintain Labeling Tracker with up to date status
• Assist with projecting over/under allocation of labeling designer/proofreader resources and adjusting schedule to meet timeline demands
• Monitor progress and performance against the project plan.
• Attend daily morning meeting to ensure labels are being assigned to designers and proofreaders to meet timeline
• Take action to resolve operational problems and minimize delays.
• Identify, develop, and gather the resources to complete the project.
• This may include preparing and developing project schedules, budgets and forecasts.
• Liaise with other operational areas in the organization (e.g., regulatory, engineering, operations) to secure specialized resources and contributions for the project.
• Select and manage activities to ensure they are integrated into the project and the organization receives satisfactory standards of service.
• Conduct meetings and prepare reports to communicate the status of the project.
• Set priorities, execute tasks, and coordinate workstreams to meet project targets and milestones.
• Responsible for completing documentation in a timely manner and in accordance with business and quality standards
• Knowledge of the following programs would be a plus: Viewpoint, Xiam, Planview, Windchill

Job Types: Full-time, Contract

Salary: $10.00 - $32.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Temecula, CA: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• Viewpoint, Xiam or Planview or Windchill: 2 years (Preferred)
• regulatory labeling: 2 years (Preferred)
• pharma or medical device industry: 2 years (Preferred)
• Project management: 2 years (Preferred)

Work Location: One location