Regulatory Artwork Coordinator

2 months ago


Sandwich, Kent, United Kingdom Pfizer Full time
Job Summary

The successful candidate will serve as a key member of the Artwork Management team, responsible for coordinating and implementing artwork-related activities across multiple departments and regions. This role requires strong communication and project management skills, as well as the ability to work independently with minimal supervision.

Key Responsibilities
  • Artwork Request Management: Initiate and build Pfizer Artwork Requests (PARs) in collaboration with local markets, ensuring all required information, specifications, and documentation are available for production.
  • Change Control Logistics: Negotiate Artwork Change Control logistics across multiple departments and markets to ensure Regulatory timelines are met and product supply is not interrupted.
  • Tracking and Reporting: Track artwork, Key Performance Indicators (KPIs), and quality metrics for assigned projects and regional or departmental deliverables.
  • Quality Investigations: Research root cause assessments for internal artwork Quality Investigations or meetings, identify opportunities for continuous improvements, and prepare formal recommendations to artwork management leadership.
  • Document Retrieval and Reporting: Retrieve documents and/or generate reports in response to queries from Regulatory Agencies or Assistant General Counsel.
Additional Responsibilities
  • Project Coordination: Represent Artwork and Launch Implementation Management (ALIM) on various cross-functional projects, or lead ALIM continuous improvement teams.
  • Market Liaison: Liaise with markets and stakeholders to gather necessary information to initiate and build PARs, enabling plant production of Labeling Artwork with minimal rework.
  • Editor's Copy Creation: Create Editor's Copy (EC) for select markets depending on language(s) involved and specific custom services negotiated with markets.
  • Stakeholder Coordination: Liaise with Global Regulatory Operations, Global Label Management/International Labelling Group functions, GRS PCOs, and PGS AWCs to coordinate unique factors, document agreement on Artwork timelines, and escalate issues/concerns within ALIM functional line and/or relevant leadership.
Requirements
  • Biopharmaceutical Packaging & Artwork Knowledge: Utilize knowledge of Biopharmaceutical Packaging & Artwork, Trade Dress Style Guides, Country Specific Requirements, and other guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs.
  • Proofreading and Quality Assurance: Review proofreading report, resolve technical formatting questions or errors, and assure necessary proofreading of final printed Artwork against EC is completed using appropriate tools.
  • Rework and Approval Management: Initiate, manage, and track any necessary rework, identify Market Approvers for Packaging Artwork, and electronically route for approval using artwork lifecycle management system.
  • Communication and Collaboration: Communicate final approved labelling to relevant departments and stakeholders, upload locally reconditioned or repackaged Artworks into artwork management system, and lead teams in development and revisions of relevant SOPs for functional area.


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