The Labeling Project Specialist (LPS) supports the R&D team by planning, managing, and directing the creation and revision of product literature and labeling. The LPS ensures labeling content complies with applicable procedures and regulations, coordinates deliverables, and acts as the primary expert for product labeling.
Key Responsibilities:
- Coordinate and manage all product labeling deliverables, including labels, IFUs/DFUs, carton, and pouch artwork.
- Develop labeling plans, schedules, and milestones; track progress and communicate status to stakeholders.
- Collaborate with cross-functional teams to create, revise, and review labeling content.
- Ensure deliverables are accurate, compliant, and consistent across projects.
- Manage implementation and release activities through the Document Control System.
- Identify and drive continuous improvement opportunities in labeling processes.
Qualifications:
- Associate or Bachelor's degree.
- 4+ years of experience in a regulated industry (medical device preferred).
- 2+ years of product labeling or technical writing experience.
- Proficiency in Adobe Creative Suite, MS Office, and MS Project; experience with NiceLabel or Bartender preferred.
- Project management experience; familiarity with Scrum and Agile methodologies is a plus.
Required Skills:
- Strong product labeling experience in a regulated environment.
- Excellent project management and cross-functional collaboration skills.
- High attention to detail and ability to meet deadlines.