MedZilla

ProClinical is recruiting for an exciting new contracted position of Labeling Project Coordinator opening up in Foster City, CA.

• Responsible for the coordination of new labeling implementation with Materials Management and Supply Chain Planners at multiple packaging sites worldwide.
• Allocates workload to ensure availability of required artwork for the full product range in compliance with new product approvals and existing product variation approval deadlines.
• Liaises with international and local regulatory colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met.
• Contributes to the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
• Manages complex workflows in an electronic labeling management system.
• Recommends improvements and develops systems/policies to enhance labeling operations.
• Authors standard operating procedures, guidelines and work instructions.
• Collaborates with team members to meet departmental goals and objectives.
• Completes labeling artwork updates as assigned.

Skills And Qualifications:

• Highly capable at directing and coordinating project work.
• Strong verbal, technical writing and interpersonal skills.
• Proficient in Microsoft Office applications.
• Knowledge of FDA and cGMP standards, as well as regulatory guidance documents.
• Prior experience in pharmaceutical or other regulated industry is preferred.
• Familiarity with artwork production and graphic design software a bonus.
• 6+ years relevant experience and a BS or BA or 4+ years relevant experience and an MS.