Packaging and Labeling Design Specialist

4 weeks ago

Collegeville, United States Pioneer Data Systems Full time
Position Details:
Our client, a world-leading Pharmaceutical Company in Collegeville, PA or Lake Forest IL is currently looking for an Pharma Labeling Change Control Coordinator to join their expanding team.

Job Title: Pharma Labeling Change Control Coordinator / Hybrid Work
Duration: 18 months contract, extendable up to 36 months
Location: Collegeville, PA or Lake Forest IL
This is a hybrid role, candidates must be located in either Collegeville, PA or Lake Forest IL

Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan

Job Description:
Packaging and Labeling Design Specialist

Summary:
This is a project management and troubleshooting role that liaises between local Pharmaceutical Markets and relevant Manufacturing Plants or Artwork Centers (AWCs) to assure timely implementation of artworks for labeling on packaging components according to local Regulatory Agency requirements.

This role coordinates Artwork Change Control workflows for assigned products, markets and, vendors in Client's electronic Packaging Artwork and Labeling System (ePALMS).
In some cases, this role also negotiates Artwork Implementation requirements across clusters of markets with conflicting requirements and may sometimes work across regions.
Incumbent actively engages with key Packaging and Labeling Artwork stakeholders in Global Regulatory Affairs (GRA), Global Labeling Management (GLM), International Labeling Group (ILG), Client Global Supply (PGS) plants as well as relevant PGS Demand Management functions.
They often take the lead in negotiating Regulatory timelines for Artwork Implementation on Product Labeling and associated packaging components, taking into account conflicting drivers across markets and/or stakeholders to ensure regulatory requirements are met and product supply is not impacted.
Colleague fundamentally performs the ePALMS system "Market Coordinator (MC) role in close collaboration with the Global Regulatory Affairs (GRA) Strategy functions at Pharmaceutical Country Offices (PCOs) and is the central regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a subject matter expert (SME) centralized "hub capacity and in some cases, may perform Regulatory Strategist roles & responsibilities where specific tasks are delegated and in line with local and global SOPs/Work Instructions.

Responsibilities:
Initiation and "build of Pharmaceutical Artwork Requests (PARs) using electronic artwork change management system in collaboration with local markets (PCOs), assuring all required information, specifications and/or supportive documentation is available for plants/AWCs to execute the production of product Labeling related packaging components
Negotiating Artwork Change Control logistics across multiple Pharmaceutical departments (as well as multiple markets) to assure Regulatory timelines for Implementation are met and that product supply is not interrupted
Liaises with markets and stakeholders to gather all necessary information to initiate and "build PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet Implementation requirements
Create Editor's Copy (EC) for select markets depending on language(s) involved and specific "custom services negotiated with markets in line with SOPs
Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed Artwork against EC is completed using appropriate tools; escalates any issues, questions or errors within ALIM functional line or appropriate markets for adjudication as needed.

Qualifications:
Bachelor's degree in a related discipline
A minimum of 4-8+ years of related work experience, with a minimum of 2+ years of which are in a Labeling Artwork Change Control & Implementation Management capacity or in roles such as Regulatory Strategy, Demand Management, Quality Operations or Supply Chain capacity which have frequent interactions with ALIM related activities specifically to Artwork Change Control and Implementation
Experience with Document Management Systems and Electronic Artwork and Labeling Management Systems
Experience with business analytic tools such as Spotfire, Tableau, SAP Business Objects, etc.
Experience with copy editing tools such as Acrobat Professional
Experience with document management lifecycle tools
Proficient in the use of Microsoft Word and Excel
Proofreading system knowledge is preferred
Artwork and labeling familiarity required
FDA labeling and packaging regulation knowledge
Experience with regulatory strategy or QA labeling/packaging preferred
Pharmaceutical packing experience preferred
Experience with data management systems a plus

Location:
This is a hybrid role, candidates must be located in either Collegeville, PA or Lake Forest IL

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