Clinical QC Reviewer

RESPONSIBILITIES
Independently performs Document Quality Review of assigned clinical, regulatory or publication documents (eg clinical components of submission documents, CSRs, Investigator Brochures).
Formally documents DQR findings of assigned documents. Alerts supervisor and document authors immediately if significant problems are found.
After completion of DQR, prepares written report of findings.
Participates in resolution of findings with the document authors and if necessary, unit head/manager.
Keeps management and authors informed on progress of document quality reviews.
Archives relevant DQR documentation of the completed DQR
May initiate the preparation of project style guides and coordinate agreement on style issues across projects.
Records assignments in relevant tasks logs.
Provides monthly and quarterly reports with type and number of documents completed in a workload tracking database and uses queries to sort for quarterly statistics

SKILLS:

QUALIFICATIONS
4 + years of Quality Assurance experience required. Demonstrate high attention to detail, ability to work independently, and have the ability to review data across multiple documents for consistency, accuracy and completeness of overall messaging. Must be able to actively participate in cross-functional clinical teams and provide deliverables according to timelines. Bachelor's Degree in a scientific or related field is required and that clinical and medical writing experience is preferred.