Technical Writer

Integrated Resources, Inc ( IRI ); Saint Paul (MN); Hybrid; USD 55,000 - 61,000; Full time

Job summary

Integrated Resources, Inc (IRI) is seeking a Labeling Project Specialist to plan, manage, and direct creation and revision of product literature and labeling for medical devices. The role requires collaboration with project teams to ensure labeling content meets procedures and quality standards.

The candidate will coordinate deliverables from initiation through completion, develop schedules, secure resources, and ensure on-time delivery.

Qualifications

• 4+ years’ work experience in regulated industry.
• Medical Device Experience
• 2+ years Labeling experience
• Direct labeling or technical writing experience (preferred)

Responsibilities

• Coordinate labeling deliverables including labels, IFUs/DFUs, and carton/pouch artwork.
• Lead cross-functional teams through content development for labeling deliverables.
• Develop deliverable schedules and milestones; track progress and report status.
• Monitor dependencies and mitigate schedule or quality risks; ensure regulatory compliance.

Skills

Regulated industry experience

Medical Device Experience

Labeling experience

Tools

Adobe Creative Suite

MS Project

MS Office

Job description

Hybrid position - 3 days onsite and 2 days remote

Duration: 12 months W2 contract with high possibility of extension based on performance and depending on business needs

Pay Range: $40 to $44/Hour on W2

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.

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:

4+ years’ work experience in regulated industry.

Medical Device Experience

2+ years Labeling experience

Preferred Qualifications:

Direct labeling or technical writing experience

Medical Electrical Equipment/ Capital Equipment experience

Adobe Suite Creative Suite experience strongly preferred.

MS Office and MS Project experience strongly preferred.