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Project Coordinator
Ref No.: 18-46548
Location: Boulder, Colorado
Start Date / End Date: 08/20/2018 to 08/30/2019
Company: Artech Information Systems
Job Title:  Project Coordinator
Location: Boulder, CO
Duration: 12+ months
Job Id: 18-46548
Responsible for the project coordination of labeling and translation projects, including UDI and GTIN allocations for the GDS - Technical Communications department. Projects include R&D product development, sustaining activities, new acquisitions, and manufacturing transfers for all products produced by the Healthcare Minimally Invasive Therapies Group. Must ensure customer requirements are met and departmental processes are followed to comply with Healthcare standards.
  • Ensures customer requirements necessary for the generation of label copy for product documentation, packaging, and product artwork. Works closely with functional areas to define labeling requirements and project expectations, ensuring compliance with regulatory and legal regulations and standards, and addressing questions from project teams.
  • Effectively manages multiple projects, changes in project scope, and shifting priorities in order to maintain project requirements and ensure deadlines are met.
  • Manages label review meetings to obtain approvals and/or answer questions related to artwork.
  • Collaborates with department and cross-functional peers to ensure proper resolution to questions and issues during the artwork development process.
  • Manages the translation process as necessary for all approved English label copy.
  • Supports UDI and GTIN department lead in a backup capacity. Support role to assign GTIN’s and create UDI documents that will be reported and maintained in PMDM and externally to the GUDID.
  • Provides support and status updates to key project team and label review members as necessary throughout project duration.
  • Continually reviews labeling and translation development processes to ensure quality in output.
  • Excellent communication, organizational and project management skills.
  • Ability to learn or have previous experience with Agile
  • Working knowledge of PC software, including Excel, Word, PowerPoint, Project, and manufacturing ERP and PLM systems.
  • Ability to work with department peers and middle-management within the regulatory marketing, engineering, and manufacturing departments, contract manufacturers and external suppliers.
  • Self-starter with high degree of accountability
  • Four-year college degree (or equivalent).
  • Previous experience in labelling coordination required with focus on leading cross-functional teams.
  • Background in regulatory or product labelling preferred.
Rajiv Maruthi