QC Reviewers/Medical Writer (Contract)
San Jose, CA
3 to 6 months, with possibility of an extension
Consultant will provide quality control (QC) review services. Contractors must be able to work onsite, on a full-time basis, at our office in San Jose.
- Perform QC review of Investigator’s Brochures, protocols, clinical study reports, IND, BLA, MAA, or other regulatory submissions, and other clinical documents.
- Review documents for internal consistency of information, consistency with source documents, compliance with regulatory requirements and client procedures, and/or per other scope as needed.
- Other duties as assigned.
- Bachelor’s or advanced degree in a technical discipline with at least five years in the industry as a medical writer and/or QC reviewer.
- Knowledge of or aptitude for understanding medicine; familiarity with the drug development process and regulatory documentation.
- Understand drug development including the various trial phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
- Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production.
- Must be able to gather and synthesize large amounts of data.
- Attention to detail and produces accurate work, even when under pressure; check the accuracy of information before using it or passing it on to others.
- Demonstrated ability to accurately edit clinical documents.
- Understand the role of various documents relevant to drug development in an international environment.
- Proficient computer skills, with applications such as MS Office that include Word, PowerPoint, and Outlook. Competency in a software application for managing references
Send your resume, in Microsoft Word format, WITH salary requirements, AND a cover letter saying why you’re a good fit for the position to: email@example.com.