Job Summary
An information technology and data science consultancy is in need of a Remote Regulatory Documentation and Submissions Medical Writer in San Mateo.
Core Responsibilities Include:
- Performing high-quality reviews of regulatory deliverables
- Serving at the primary RDS Quality point-of-contact
- Acting as a departmental RDS Quality resource
Applicants must meet the following qualifications:
- 4+ years of relevant experience within clinical R&D or regulatory affairs
- 2 or more years of relevant experience in a medical writing/clinical submissions environment
- Familiar with Phase 1 to 3 clinical protocols and study reports
- Understand the drug development process leading to marketing applications
