LABELING DEVELOPMENT COORDINATOR (ADX-231-19)
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THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
POSITION SUMMARY:
Within the Regulatory Operations team, the Labeling Development Coordinator will help create, implement and maintain the labeling development process within the Archer Quality Management System (QMS). The role is responsible for designing compliant product labeling and collaborating with key functions for proper implementation.
RESPONSIBILITIES:
- Development, implementation, execution, and maintenance of medical device labeling processes
- Creation of labeling requirements based on project goals, laws, regulations and applicable standards
- Interact with key functions to gather product requirements for labeling development
- Creation of source files and artwork for product labeling
- Responsible to create change orders within the QMS to publish labeling
- Work closely with Manufacturing Operations for labeling implementation
- Host and document recurrent meetings to support labeling needs from product portfolio program
- Project owner for labeling content translations
- ArcherDX’s prime contact for translation supplier management
- Purchase order originator for translation projects
- Support new product global regulatory submissions by providing draft labeling on a timely manner
- Identification and development of project/process improvement opportunities
QUALIFICATIONS:
- Proficiency in core Adobe Creative Suite design products: Photoshop, Illustrator, In Design
- HTML and content management systems knowledge
- High proficiency with MS Office suite
- Experience with ISO 13485:2016 & 21CFR820 quality systems within regulated medical device space
- Working knowledge of the translation process
- Experience with third-party supplier management
- Detail-oriented with strong communication and organization skills
- Proactive disposition with the ability to work well independently and within teams
- Ability to work within a fast-paced dynamic team environment supporting multiple projects
- Excellent eye for quality and sense of aesthetics
- Knowledge of medical device labeling standards such as ISO 28219, ISO 15223 and ISO 17100
- Project coordination/management experience
- Solid and/or dotted line management experience is a plus
- PMP certification or equivalent experience is a plus
EDUCATION:
- Minimum B.S./B.A. or equivalent experience (2-5 years)
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