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MDR - Project Coordinator II

Company: Planet Pharma
Location: Boulder
Posted on: November 19, 2021

Job Description:

POSITION SUMMARY: Responsible for the project coordination of labeling development and approval, including project definition, artwork development, translation and label copy review. Projects include R&D product development, sustaining activities, new acquisitions and manufacturing transfers for all products produced by the--Minimally Invasive Therapies Group. Required to collect business and internal customer requirements and ensure standardization of artwork development, in order to develop artwork in compliance with company Design standards. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Collect customer requirements necessary for the generation of label copy for information books/manuals, packaging and product artwork. This includes working with various departments to define labeling requirements and project expectations, ensuring compliance with Regulatory and Legal regulations and standards, and addressing any questions that arise from the project team. * Effectively manage multiple projects, changes in project scope, and shifting priorities in order to maintain project requirements and ensure deadlines are met. * Hold label review meetings, as necessary, to obtain approvals and/or answer question related to the artwork. * Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues that arise during the artwork development process. * Manage the translation process with the translation agency as necessary, for all Approved English label copy. * Provide support and status updates to key project team members and Label Review Committee Members as necessary throughout the duration of projects. * Continually review labeling processes to ensure quality in labeling output. JOB QUALIFICATIONS: * Ability to work with departmental peers and middle-management within the Marketing, Engineering and Manufacturing departments. * Excellent communication and organizational skills EDUCATION: * Four-year college degree (or equivalent). * Understanding of label printing applications and regulatory requirements. * Knowledge of PC including Excel, Word, PowerPoint, Project, and manufacturing ERP and PLM systems. EXPERIENCE: * Previous experience in project management required, with focus on leading cross-functional teams. * Background in Marketing or Product Labeling preferred. --

Keywords: Planet Pharma, Boulder , MDR - Project Coordinator II, Other , Boulder, Colorado

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