Description:
- 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.
Knowledge, Experience and Skills:
- 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 of relevant experience and a BS or BA.
- 4+ years of relevant experience and a MS.