Labeling Project Manager

About This Role

This role involves managing the development and localization of client's final packaging and labeling deliverables for medical device or pharmaceutical products. The position requires strong project management skills to ensure timely completion through effective planning, execution, and collaboration with cross-functional teams.

Responsibilities

• Manage client's labeling projects by effectively planning, executing, and collaborating with cross-functional teams to ensure that project timelines are met
• Understand the labeling function’s role in the end-to-end project timeline and integrate labeling timelines into the overall project timelines
• Represent the labeling function on project kick-offs, status, reviews, meetings, and escalation of issues
• Effectively capture meeting summaries, decisions, action items, and communicate to stakeholders
• Create Labeling Strategy Plan for new product introductions and/or design changes
• Create and track all project related tasks in various project management tools, such as Confluence, SmartSheet, and Asana
• Identify project roadblocks or scope creep and communicate to cross-functional team members
• Utilize client’s quality management system (Master Control) to route change request and packets for updates to labeling, specifications, components, and other quality documents
• Provide thorough document/process reviews to ensure accuracy and compliance, including creating redline of changes, comparing documents utilizing a compare software tool (Beyond Compare, TVT), or visual quality reviews
• Manage labeling content review cycle and approvals to accomplish labeling verification
• Responsible for the final quality of the deliverables, communicate quality issues and process deviations/risks to management
• Collaborate with supply chain on timing of labeling updates, to reduce scrap costs, and align on printed labeling ordering strategy
• Work in partnership with regulatory, quality, user experience, document control, human factors, product development, and operation team to meet project deliverables and timelines
• Collaborate with language service provider to accomplish translation of English source files, as needed
• Recognize areas of improvement and execute labeling process improvement initiatives

Requirements

• Minimum 3 to 5 years relevant medical device or pharmaceutical labeling and project management experience
• Minimum 3 to 5 years working in a Quality Management System
• Ability to develop project plans and schedules, track that team is making deadlines
• Experience working with Language Services Providers or hands on experience with localized/foreign languages
• Endurance and tenacity to work on complex, detailed projects through completion, strategic thinker

Qualifications

• Bachelor’s or Associate degree in a related field, or equivalent experience
• Minimum 3 to 5 years relevant medical device or pharmaceutical labeling and project management experience; minimum 3 to 5 years working in a Quality Management System

Skills

* Required skills

Benefits