Job Description

Are you an experienced Technical Writer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Technical Writer to work at their company in Arden Hills, MN.

Position Summary: The primary mission is to plan, manage, and direct the creation/revision of product literature and labeling. The role involves working closely with project teams to ensure labeling content is developed per, and compliant with, all applicable procedures. Responsibilities include developing schedules and ensuring labeling deliverables are executed while maintaining a high standard of quality. This position serves as the resident expert and primary point of contact for all things related to product literature and labeling.

Primary Responsibilities/Accountabilities:

• Coordinate all product labeling deliverables, including labels, IFUs/DFUs, and carton and pouch artwork.
• Manage and coordinate creation/revision of deliverables from project initiation through completion.
• Assess the scope of each project and work with team members 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 regularly.
• Understand and coordinate/monitor completion of key dependencies from other functions.
• Address issues that could negatively impact schedule or quality with functional and project management.
• Lead cross-functional teams through content development for labeling deliverables.
• Foster and improve content consistency across labelling.
• Facilitate team reviews of labelling deliverables to ensure content is accurate, complete, and compliant.
• Coordinate desktop publishing and labelling artwork generation.
• Coordinate implementation/release activities of labelling deliverables.
• Manage content changes by focusing on accuracy and completeness.
• Implement product labelling via the Document Control System.
• Leverage expertise with labeling procedures, requirements, and quality system to ensure compliance.
• Identify and implement opportunities for continuous improvement and innovation.

Qualifications:

• Associates degree.
• 4 years work experience in a regulated industry.
• Medical device experience.
• 2 years of labelling experience.

Preferred:

• Direct labelling or technical writing experience.
• Bachelors degree.
• Medical Electrical Equipment/Capital Equipment experience.
• Adobe Creative Suite experience strongly preferred.
• MS Office and MS Project experience strongly preferred.
• Project Management experience.

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