Location: Minnetonka, MN
Duration: 18+ months (possible temp-to-hire)
Position Description:
Our medical device client is searching for a unique candidate who possesses graphics design and project management abilities and is able to excel in a highly regulated industry. This position reports through Research and Development and has a variety of dimensions to the position. The Technical Writer II/Labeling Specialist creates and maintains compliant documentation such as instructions for use, product manuals, package labels and other pertinent labeling support items. This position interacts with global personnel to coordinate and prioritize labeling project requests as prioritized by management. This includes management of the translation processes, coordination of work requests from labeling staff. Specifically this position will be involved in updating package artwork and product labels.
The Technical Writer II/Labeling Specialist will create and maintain product labeling which will require working with InDesign, Illustrator, NiceLabel, Prisymedica, Easy Label, and other comparable software systems.
This position is responsible for coordinating the compliance, accuracy, status, formalization, throughput and communication of controlled product labeling per internal and global requirements.
Principal duties and responsibilities:
1. Under minimal supervision, manages labeling projects based on prioritization from management.*
2. Coordinates labeling content and meets with SMEs as necessary.*
3. Coordinates and manages technical document foreign language translations*
4. Coordinates commercial printing and proofing to ensure that printed materials meet specifications.*
5. Creates, monitors, and communicates the status of Engineering Change Orders to ensure all deadlines are met.*
6. Interfaces with Project Team members, communicating implemented labeling changes and proposed changes to promote awareness globally*
7. Audits the methodologies and procedures to ensure compliance to standards for documentation.*
8. Creates label set content*
9. Formalizes, writes, and proofs documentation while maintaining the integrity of the secure original files*
10. Seeks to optimize and simplify documents and processes as they are developed or modified
*Essential Functions
Qualifications:
Education:
• 4 year degree in journalism, technical writing, technical communication, English or other technical field
• OR
• 2 year vocational tech degree
Experience:
• 3 to 6 years medical device manufacturing graphics (product labeling) experience/training, medical industry experience preferred.
• High attention to detail.
• Ability to manage several projects concurrently.
• Ability to learn new skills and adapt to business needs.
• Proficient in Microsoft Office Suite, InDesign, Illustrator, NiceLabel, Prisymedica, Easy Label, with strong word processing and desktop publishing skills
• Database maintenance
• Strong technical writing and editing experience
• Understanding of medical device labeling regulations and standards
• Ability to work in a fast-paced environment
• Positive professional attitude and approach to problem solving
• Candidates with previous medical device, pharmaceutical or biomedical product labeling experience is preferred.
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