Regulatory Affairs Intern (ADX-55-20)
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.
- Strong desire to be part of a dynamic, growing, and mission driven company
- Driven to thrive in a rapidly changing, fast-paced environment
- Ability to organize a plan and work with an interdisciplinary team, as well as work independently to meet project deadlines
- Excellent ability to multi-task and manage multiple priorities.
- Strong critical thinking skills
- Excellent communication and writing skills
- Demonstrated interest in regulatory affairs in drug, medical device, or IVD sectors
- Familiarity with quality systems, technical writing, and formalized governmental interaction
- Foreign language skills considered a plus
- Review and draft documentation in support of technical files for international regulatory work.
- Organize regulatory document archiving in both physical and electronic media
- Facilitate team document reviews via the tracking of actions and reconciliation of comments
- Analyze guidance documents, international standards and applicable law for relevance to Archer products to provide guidance for project teams
- Track international to-do lists for updates on progress
- Minimum of junior level in pursuit of a Bachelor’s degree, with preference for those in a scientific discipline
- Proficiency with Microsoft Office and Adobe Pro
- Strong writing skills with an acute attention to detail
- Familiar with testing and documentation methodologies
- Excellent verbal and written communicator