Labeling Project Coordinator

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Project/Study Manager (CSM/CPM)
  3. United States
North Chicago, USA
Posting date: 17 May 2021
CR.SR.37626

Proclinical is currently recruiting for a Labeling Project Coordinator with a biopharmaceutical company located in North Chicago, IL. The position will lead packaging and artwork strategy and shared label strategy across the product lifecycle. Responsibility to lead cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain to achieve the Perfect Label. Ensures assurance of supply and compliance to content for new product launches, safety updates and other core labeling programs.

Job Responsibilities:

  • Global product leadership for strategic and tactical planning for label change projects
  • Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System.
  • Project Management responsibility within the system for Production, Design and Asset workflows
  • Lead label change projects and associated deliverables for launches, site transfers, country/area specific changes and other labeling focused projects.
  • Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution.
  • Ownership and leadership role within the Packaging and Artwork Strategy
  • Lead shared label strategy development and maintenance over the product life cycle
  • Change Plan ownership for labeling operations
  • Act as owner for specific labeling business processes and assume role of documentation subject matter expert
  • Lead role to represent GLM in early development labeling work including functioning as lead for labeling launch activity.
  • Create and update artworks in accordance with Health Canada's regulations, related supporting documents and agreed timelines.
  • Review/prepare all labelling filing documentation such as Notes to reviewer, Labels and Packages Certification Form for Prescription Products, in collaboration with the Regulatory filing team.
  • Support/assist the Regulatory filing team in proactively responding to labelling clarification requests by providing Package Development expertise.
  • Proofread artwork and ensure accuracy Right First Time (RFT) of the information by ensuring alignment with under review/approved product monograph, appropriate UPC/SCC/2D Matrix codes, label drawings, artwork specifications, die lines and other technical information as required by the packaging sites.

Skills and Requirements:

  • Bachelor's Degree in Science, Engineering, Business or Supply Chain and minimum of 5 years' experience in Operations, Regulatory or Quality environment
  • Proficiency in English (both written and oral)
  • Experience working effectively across different cultures, multiple functional areas and in complex matrix environments

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-536-3075.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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