Labeling Project Specialist II

Job Description: Hybrid position - 3 days onsite.

Interviews will be onsite. Firm.

Local candidates only-

About the role:
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 to, 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 include:
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 Product 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 to 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:
Associates degree
4+ years work experience in regulated industry.
Medical Device Experience
2+ years Labeling experience

Preferred Qualifications:
Direct labeling or technical writing experience
Bachelors degree
Medical Electrical Equipment/ Capital Equipment experience
Adobe Suite Creative Suite experience strongly preferred.
MS Office and MS Project experience strongly preferred.
Project Management