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![Synectics](https://media.trabajo.org/img/noimg.jpg)
Packaging & Labeling Artwork Change Contractor
1 month ago
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 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 plants as well as relevant 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 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.
- Initiation and "build" of Artwork Requests 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 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 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
- Bachelor's degree in an appropriate discipline + 4-8 years related work experience (with a minimum of 2 years of which are in a Labeling Artwork Change Control & Implementation)
- Familiar with Document management system - Electronic Artwork and Labeling Management System
- Word and Excel
- Proof Reading System knowledge desired
- Artwork and Labeling Familiarity
- FDA Labeling/packaging regulations familiarity
- Regulatory Strategy or QA labeling/packaging background preferred
- Pharm Packing background preferred
- Data Management/System familiarity a plus
- Strong background in Pharma regulatory/labeling, Pharma Quality, and Pharma Packaging
- Management capacity or in roles such as Regulatory Strategy, Demand Management, Quality Operations or Supply Chain capacity which have frequent interactions with ALIM related specifically to Artwork Change Control and Implementation.
- Business analytic tools (e.g, Spotfire, Tableau, SAP Business Objects, etc) (2 - 4 Years)
- Copy Editing Tools (e.g., Acrobat Professional) (2 - 4 Years)
- Document management Lifecycle Tools (2 - 4 Years)
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.