Technical Writer II – Labeling Project Specialist
Work Arrangement: Hybrid (3 days onsite per week)
Candidate Requirement: Local candidates only
Position Overview
The Labeling Project Specialist (LPS) is responsible for planning, managing, and directing the creation and revision of product literature and labeling. This role serves as the primary point of contact and subject matter expert for all labeling-related activities. The LPS works closely with cross‑functional project teams to ensure labeling content is accurate, compliant, high‑quality, and delivered on schedule.
Key Responsibilities
Labeling Development & Coordination
- Coordinate all product labeling deliverables, including labels, IFUs/DFUs, carton and pouch artwork, and related materials.
- Manage creation and revision of labeling deliverables from project initiation through completion.
- Assess project scope and collaborate with project management and team members to develop labeling plans and secure resources.
- Develop schedules, establish milestones, and ensure on‑time delivery of all labeling components.
- Communicate project status, risks, and successes to project and functional leadership.
Cross‑Functional Collaboration & Content Management
- Monitor dependencies across functions and address issues that may impact schedule or quality.
- Lead cross‑functional teams through labeling content development, including drafting, collecting inputs, revising content, and tracking changes.
- Promote consistency across labeling content and ensure alignment with regulatory and quality requirements.
- Facilitate team reviews to ensure labeling is accurate, complete, compliant, and customer‑focused.
Publishing, Release & Compliance
- Coordinate desktop publishing and artwork generation.
- Manage implementation and release activities for labeling deliverables.
- Oversee content changes and mitigate schedule impacts by ensuring accuracy and completeness.
- Implement labeling through the organization’s Document Control System.
- Apply expertise in labeling procedures, requirements, and quality systems to ensure error‑free deliverables.
- Identify opportunities for continuous improvement and drive innovation in labeling processes.
Qualifications
- 4+ years of experience in a regulated industry
- Medical device industry experience
- 2+ years of labeling experience
Preferred Qualifications
- Direct labeling or technical writing experience
- Experience with medical electrical equipment or capital equipment
- Strong proficiency with Adobe Creative Suite
- Proficiency with MS Office and MS Project
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Writing/Editing
Industries
Medical Equipment Manufacturing
Benefits
- 401(k)
- Vision insurance
- Medical insurance
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