Labeling Development Coordinator (ADX-231-19) at ArcherDX
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.
- 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
- 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
- Minimum B.S./B.A. or equivalent experience (2-5 years)