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Project Manager - Technical I
- Collegeville, Pennsylvania, United States
- Collegeville, Pennsylvania, United States
Über
Responsible for implementation of new or revised labeling artwork for the company's Biopharmaceutical products. Colleague coordinates Artwork change control workflows for assigned products, markets, and/or vendors. Colleague fundamentally performs the ePALMS system (electronic Artwork and Labeling Management System) "Market Coordinator" role on behalf of WSR Regulatory Strategy functions at Country Offices (PCOs) and is the central Regulatory point of contact for the PGS (Global Services) plants/artwork centers.
Position Responsibilities:
- Initiate and "build" 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 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
- 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.
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, Pfizer 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).
Position Comments visible to MSP and Supplier: Must have pharmaceutical experience in labeling, regulatory, or packaging.
What is the minimum education experience required?: Bachelor's degree plus 1 4 years relevant work experience
All your information will be kept confidential according to EEO guidelines.
Sprachkenntnisse
- English
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