Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards.
Drive process improvements related to artwork development, approval workflows, and digital tools.
Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed.
Maintain artwork issue logs and attend escalation meetings to provide updates.
Identify inefficiencies and escalate to Hub Leads when required.
Participate in content lock meetings to ensure stakeholder alignment.
Manage Veraciti system-related issues and escalate appropriately.
Suggest and implement technology solutions for artwork and labeling processes.
Create, update, and maintain training documentation for systems and processes.
Supervise Artwork Controllers to ensure task completion and provide support during peak periods.
Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices.
Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment.
Track and follow up on action items from cross-functional meetings.
Communicate project status, risks, and milestones consistently to stakeholders.
Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates.
Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives.
Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required.
Conduct design-to-press color management assessments and feasibility consultations.
Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks.
Address process and executional quality issues; support system and process improvements.
Manage ad-hoc artwork-related requests and cascade process/system communications.
Qualifications & Experience
Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field;
10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries.
Strong knowledge of global regulatory requirements for product labeling and packaging.
Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment.
Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva).
Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro).
Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.).
Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation.
Six Sigma Green Belt certification or equivalent experience in continuous improvement.
Excellent communication, problem-solving, and organizational skills.
PMP certification or formal project management training is a plus.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Keywords: Regulatory Affairs, Labeling, Artwork, packaging, consumer products
#LI-PR1 #LI-REMOTE #Manager #Contract
