Senior Document Quality Reviewer

Senior Document Quality Reviewer

The Senior Document Quality Reviewer (DQR) will conduct document quality review of medical writing deliverables and ensure timely delivery of error-free, high-quality clinical documents by correcting errors in grammar, style, syntax, and format ensuring accuracy of the clinical data and content presented, identifying and fixing flaws in logic and flow, and following appropriate style guides/templates. The Senior DQR will independently provide editing support for more complex clinical documentation.

Minimum Work Experience:

• Previous experience in authoring or reviewing PBRER, ACOs, PADERs and other aggregate safety reports is desirable Experience in the pharmaceutical or clinical research organization industry and medical writing.

• Expertise in writing and/or quality reviewer of pharmacovigilance documents including but not limited to - PBRER, PSUR, DSUR, RMP, ACO, PADER is essential.

• Knowledge of regulatory documents and ICH-GCP guidelines, understanding of clinical research, and the drug development process.

• Proof reading, quality control and copyediting experience.

• Advanced word processing skills, including MS Office; software and systems knowledge or ability to learn and adapt to various IT systems; document management systems, collaborative authoring and file conversion and databases.