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Packaging Development Specialist
1 month ago
Title: Packaging & Labelling Artwork Change Contractor
Location: Collegeville, PA & Lake Forest, IL - Hybrid
Duration: 06+ Months (Possible Extension)
Job Description:
- This is a project management and troubleshooting role that liaises between local *** 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 ***’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), *** 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 assure 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 *** 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 include:
- Initiation and “build” of *** 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 *** 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 aProductst EC is completed using appropriate tools; escalates any issues, questions or errors within ALIM functional line or appropriate markets for adjudication as needed.
Hard Skill:
- Document management system - Electronic Artwork and Labeling Management System
- Word, Excel
- Proof Reading System Knowledge - Nice to have
- Artwork and Labeling Familiarity
- FDA Labeling/packaging regulations familiarity
- Regulatory Strategy or QA labeling/packaging BG - Preferred
- Pharm Packing BG - Nice to Have
- Data Management/System familiarity a plus
If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.
Thank you for your time and for your consideration. I look forward to hearing from you.