Labeling Project Specialist (LPS)

TALENT Software Services; Saint Paul (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

TALENT Software Services seeks a Labeling Project Specialist to plan, manage, and direct creation/revision of product literature and labeling. You will lead cross-functional teams, ensure compliance, and deliver labeling content per procedures.

You will coordinate schedules, monitor milestones, and optimize labeling processes while maintaining high quality and regulatory alignment across projects.

Qualifications

• Requires an Associate's degree and 4+ years in a regulated industry.
• 2+ years of labeling experience in a regulated setting.
• Medical Device experience is required or strongly preferred.

Responsibilities

• Coordinate labeling deliverables across projects, including labels, IFUs/DFUs, and artwork.
• Develop labeling plans and schedules, securing resources and tracking milestones.
• Lead cross-functional teams to ensure content accuracy, regulatory compliance, and on-time deliverables.

Skills

Project management

Technical writing

Regulatory/compliance

Education

Associate's degree

Bachelor's degree

Tools

Adobe Creative Suite

MS Office

MS Project

Job description

The primary mission for the Labeling Project Specialist (LPS) is to plan, manage, and direct the creation/revision of product literature and labeling. The LPS works closely with project teams to ensure labeling content is developed per and compliant with all applicable procedures. They develop schedules and ensure labeling deliverables are executed to them while maintaining a high standard of quality. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling.

Responsibilities

• Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, etc.
• Manage and coordinate creation/revision of deliverables from project initiation through completion.
• Assess the scope of each project and work with team members and project management to create labeling plans and secure necessary resources.
• Develop deliverable schedules and establish milestones for tracking progress. Ensure on-time completion of deliverables, and communicate project status, challenges, and successes on a regular basis to project and functional management.
• Understand and coordinate/monitor completion of key dependencies from other functions.
• Monitor and, when necessary, work with functional and project management to address issues that could negatively impact schedule or quality.
• Lead cross-functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule.
• Foster and improve content consistency across labeling.
• Facilitate team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant with relevant regulations and requirements, and meets the needs of the customer.
• Coordinate desktop publishing and labeling artwork generation.
• Coordinate implementation/release activities of labeling deliverables.
• Manage content changes (and mitigate their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
• Implement product labeling via ***'s Document Control System.
• Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.
• Identify and implement opportunities for continuous improvement and innovation.

Minimum Requirements

• Associate's degree
• 4+ years' work experience in a regulated industry.
• Medical Device Experience
• 2+ years of labeling experience

Preferred Qualifications

• Direct labeling or technical writing experience
• Bachelor's degree
• Medical Electrical Equipment/ Capital Equipment experience
• Adobe Creative Suite Experience Strongly Preferred.
• MS Office and MS Project experience strongly preferred.
• Project Management