QC Reviewers/Medical Writer (Contract)

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

To Apply:

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: hr@icg-sj.com.