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ClinChoice

Labeling Artwork Controller Consultant at ClinChoice

BrazilFull-timeRegulatory AffairsPosted 4 months ago
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About the Role

<p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is searching for a&nbsp;<strong>Labeling Artwork Controller Consultant for 12 months Contract with possibility of extension&nbsp;</strong>to join one of our clients.</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. &nbsp;</span></p> <p>&nbsp;</p> <p><strong>Job Description</strong></p> <p><strong><u>Artwork Controller</u></strong></p> <p><strong>Role Summary</strong></p> <p>The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.</p> <p><em><u>&nbsp;</u></em></p> <p><em><u>Key Responsibilities:</u></em></p> <ul> <li>Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components.</li> <li>Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies.</li> <li>Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies.</li> <li>Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects.</li> <li>Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards.</li> <li>Drive process improvements related to artwork development, approval workflows, and digital tools.</li> <li>Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed.</li> <li>Maintain artwork issue logs and attend escalation meetings to provide updates.</li> <li>Identify inefficiencies and escalate to Hub Leads when required.</li> <li>Participate in content lock meetings to ensure stakeholder alignment.</li> <li>Manage Veraciti system-related issues and escalate appropriately.</li> <li>Suggest and implement technology solutions for artwork and labeling processes.</li> <li>Create, update, and maintain training documentation for systems and processes.</li> <li>Supervise Artwork Controllers to ensure task completion and provide support during peak periods.</li> <li>Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices.</li> <li>Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment.</li> <li>Track and follow up on action items from cross-functional meetings.</li> <li>Communicate project status, risks, and milestones consistently to stakeholders.</li> <li>Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates.</li> <li>Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives.</li> <li>Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required.</li> <li>Conduct design-to-press color management assessments and feasibility consultations.</li> <li>Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks.</li> <li>Address process and executional quality issues; support system and process improvements.</li> <li>Manage ad-hoc artwork-related requests and cascade process/system communications.</li> </ul> <p>&nbsp;</p> <p><em><u>Qualifications &amp; Experience:</u></em></p> <ul> <li>Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field;</li> <li>10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries.</li> <li>Strong knowledge of global regulatory requirements for product labeling and packaging.</li> <li>Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment.</li> <li>Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva).</li> <li>Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro).</li> <li>Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.).</li> <li>Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation.</li> <li>Six Sigma Green Belt certification or equivalent experience in continuous improvement.</li> <li>Excellent communication, problem-solving, and organizational skills.</li> <li>PMP certification or formal project management training is a plus.</li> </ul> <p>&nbsp;</p> <p style="line-height: 1;"><strong><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Key Words: </span></strong><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Regulatory Affairs, Artwork, Labeling design, proofreading</span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">#LI-PB1 #LI-REMOTE</span></p> <p>&nbsp;</p> <p>&nbsp;</p>

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