Technical Writer

Technical Writer II / Labeling Project Specialist

Location: Arden Hills, MN

Job Type: Year Long Contract with opportunity to extend

Work Arrangement: Hybrid (3 days onsite per week)

Pay Rate: Up to $45.00/hour or about $90,000 a year

Work Authorization: Applicants must be legally authorized to work in the United States without current or future visa sponsorship. Sponsorship is not available for this position.

Position Overview

We are seeking a Technical Writer II / Labeling Project Specialist (LPS) to support the planning, development, management, and implementation of product labeling and technical documentation for medical devices. This role serves as the primary point of contact for labeling activities and works cross-functionally to ensure all product literature and labeling deliverables are completed on schedule, meet quality standards, and comply with applicable regulatory and quality system requirements.

The ideal candidate will have experience in a regulated industry, strong project coordination skills, and hands-on experience managing labeling deliverables throughout the product lifecycle.

Key Responsibilities

Labeling & Documentation Management

• Coordinate and manage all product labeling deliverables, including:
• Labels
• Instructions for Use (IFUs)
• Directions for Use (DFUs)
• Carton artwork
• Pouch artwork
• Additional product literature and labeling materials
• Lead labeling projects from initiation through completion, ensuring deliverables meet quality, regulatory, and timeline requirements.
• Assess project scope and develop labeling plans in collaboration with project teams and management.
• Develop project schedules, establish milestones, and track progress to ensure on-time completion of deliverables.
• Serve as the subject matter expert and primary contact for labeling-related activities.

Cross-Functional Project Coordination

• Collaborate with project teams, regulatory affairs, quality, engineering, marketing, and other stakeholders to develop labeling content.
• Facilitate content development by collecting source information, managing drafts, tracking revisions, and coordinating reviews.
• Monitor project dependencies and proactively address issues that could impact quality or schedule.
• Communicate project status, risks, challenges, and successes to project and functional leadership.

Quality & Compliance

• Ensure labeling content is accurate, complete, and compliant with applicable regulations, standards, and internal procedures.
• Facilitate review and approval processes to verify content accuracy and regulatory compliance.
• Implement product labeling through Boston Scientific’s Document Control System.
• Leverage knowledge of labeling procedures, quality systems, and regulatory requirements to ensure error-free deliverables.

Process Improvement

• Promote consistency across labeling content and documentation.
• Identify and implement opportunities for continuous improvement, efficiency, and innovation within labeling processes.
• Coordinate desktop publishing and labeling artwork generation activities.
• Support implementation and release activities for labeling deliverables.

Minimum Qualifications

• Associate’s degree required.
• 4 years of experience in a regulated industry.
• 2 years of product labeling experience.
• Experience within the medical device industry.
• Strong organizational, communication, and project coordination skills.
• Ability to manage multiple projects and deadlines simultaneously.

Preferred Qualifications

• Bachelor's degree.
• Direct technical writing and/or labeling experience.
• Experience with medical electrical equipment or capital equipment products.
• Proficiency with Adobe Creative Suite (strongly preferred).
• Experience using Microsoft Office and Microsoft Project.
• Project management experience.
• Familiarity with document control systems and change management processes.

Ideal Candidate Profile

• Experienced in medical device labeling and technical documentation.
• Strong project management and cross-functional coordination skills.
• Detail-oriented with excellent organizational abilities.
• Comfortable working in a highly regulated environment.
• Able to manage multiple priorities while maintaining a high level of quality and compliance.