About this opportunity
PSG Global Solutions lists this Project Manager - Technical I opportunity in collegeville, Pennsylvania. Review the employer’s description below for duties, qualifications and application requirements.
Job description
JOB TITLE: Project Manager - Technical I
CLIENT: A prominent Pharmaceuticals Company
CONTRACT: 12 months initial contract (5/22/2017 )- there is a possibility of extension
LOCATION: Collegeville - PA 19426
Pay Rate: To be discussed over the phone
POSITION SUMMARY
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, 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).
Position Comments visible to MSP and Supplier: Must have pharmaceutical experience in labeling, regulatory, or packaging.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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Worksite address
collegeville, PA, 19426, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.