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Quality Assurance - Clinical I
Ref No.: 17-15490
Location: Lake Forest, Illinois
Job Description: POSITION SUMMARY:
Responsible for implementation of new or revised labeling artwork for Pharmaceutical Biopharmaceutical products.
Colleague coordinates Artwork change control workflows for assigned products, markets, and/or vendors.
Colleague fundamentally performs the ePALMS system (electronic Pharmaceutical Artwork and Labeling Management System) “Market Coordinator” role on behalf of WSR Regulatory Strategy functions at Pharmaceutical Country Offices (PCOs) and is the central Regulatory point of contact for the PGS (Pharmaceutical Global Services) plants/artwork centers.

POSITION RESPONSIBILITIES:
• Initiate and “build” Pharmaceutical Artwork Requests (PARs) on behalf of Markets, assuring all required information, specifications and/or supportive documentation is available for plants/artwork centers to execute the production of product labeling related packaging components.
• Liaises with market stakeholders and PGS plant and artwork centers, or demand management lines to coordinate any unique factors that need to be considered; documents agreement on artwork timelines across stakeholders; escalates any issues/concerns within ALIM functional line and/or relevant leadership for adjudication as necessary.
• Coordinate artwork change control logistics across multiple Pharmaceutical departments to assure regulatory timelines for implementation are met and that product supply is not interrupted.
• Support large-scale artwork change control projects with broad portfolio impact under the direction of more senior ALIM staff.
• Evaluates content of labeling updates and raises potential issues with WSR, PGS or relevant local Markets as appropriate to minimize impact on schedules.
• Retrieve documents and/or generate reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to labeling in distribution).

ORGANIZATIONAL RELATIONSHIPS:
• ALIM Market Implementation Specialists
• Regulatory Strategists
• Pharmaceutical Global Services – Plant Coordinators and Artwork Centers
• Proofreaders (internal and external)
• Supply Demand Management Leads
• Marketing

EDUCATION AND EXPERIENCE:
• Bachelor’s degree plus 1 – 4 years relevant work experience.
• Substantial additional relevant experience may be considered in lieu of degree; or an advanced degree in an appropriate relevant discipline may be considered in lieu of some experience.

TECHNICAL SKILLS REQUIREMENTS:
• Document management tools used for storage, retrieval, and lifecycle management of labeling related secondary packaging components (e.g. ePALMS, GDMS - Global Document Management System, Agile, Pfzer Labeling End to End Tracking – PfLEET, or similar systems).
• Packaging artwork review, copy editing or proofreading tools (e.g. Docu-Proof, TVT or similar tools).

COMPETENCIES – This section is Optional to complete.

Regulatory/Pharmaceutical Manufacturing/Packaging GMP Knowledge---Must be familiar with Biopharmaceutical Regulatory environment and cGMPs (current Good Manufacturing Practices) associated with manufacturing, packaging & distribution processes as well as a basic understanding of artwork & labeling regulations and controls.

Strong Verbal/Written Communication Skills---Must be able to collaborate with cross-functional Pharmaceutical teams, negotiate across globally distributed affiliates & manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner.

Computer Skills---Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required.

Organizational/Management Skills---Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed.
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