Labeling Coordinator

3 weeks ago

Irvine, United States Redbock - an NES Fircroft company Full time

**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**


An established Medical Device company in Irvine, CA is in need of a Labeling Workstream Coordinator for a 2-year project. The project is based entirely on site in Irvine, it is scheduled to kick off the first week of November.


The client is a Project Manager within a large company who has put a labeling group that will push out a large number of labels each week, this Coordinator needs to ensure that happens and also develop and maintain a tracking tool that will feed in to a 'Master Tracker' spreadsheet. This project is a unique opportunity to support a leading global organization to play an integral role within a new and growing team.


We are seeking a Coordinator with experience managing and tracking work output against a plan of a team, and a strong background of stakeholder management and communication. The ideal Coordinator will have a proven track record of managing a defined scope of work for a dedicated team of resources and providing status updates within Excel, SharePoint, Powerpoint and other common platforms. The role will involve closely interacting with a team of twelve (12) resources executing product labeling updates, redlines, proofreading and revisions as well as providing status updates and escalating issues to the Labeling Workstream Leader and Product Transfer Project Manager to ensure work output is meeting plan and any issues are being escalated and resolved.


Responsibilities:

  • Maintain and update Excel tracker of labelling team status and provide regular input updates to the Master Tracker/Technical Data Analyst.
  • Facilitate regular (3-5 times per week) status updates with the labeling workstream to track status and identify issues.
  • Collaborate with the Labeling Workstream Leadto resolve labelling workstream issues.
  • Demonstrate high-level understanding of supply chain and regulatory functional operations within a Pharmaceutical or Medical technology organization.
  • Ensure timely collection of input data from relevant team members through effective team management
  • Communicate effectively with internal stakeholders and escalate issues in a timely manner to the Product Transfer Project Manager and the Labeling Workstream Lead
  • Track progress against deadlines and report progress regularly to the Product Transfer Project Manager and Labeling Workstream Lead


Requirements:

  • BS degree minimum
  • 2-5 years of Medical Device or Biotechnology industry experience
  • Proven experience in managing and maintaining Excel trackers
  • Proficiency in providing status updates in a variety of tools including Excel, Sharepoint, Powerpoint and other commonly used platforms
  • Experience with product transfer or product lifecycle management projects
  • Knowledge of PLM, supply chain, labeling, and regulators
  • Knowledge of MDR
  • Strong communication and stakeholder management skills
  • Ability to track progress against deadlines and report outputs regularly


Nice to have experience: High-level understanding of supply chain and regulatory functional operations within a Pharmaceutical or Medical technology organization.

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