Regulatory QC Specialist

Responsible for QC review of all clinical and regulatory documents produced by NBI for all projects.  May also be required to verify nonclinical summary data.

Verifies documents and other summaries for accuracy against external sources (e.g., raw data), internal consistency, grammar, punctuation, and style.

Responsible for compiling accurate CSR appendices and ensures consistency across documents and programs.  Maintains current QC guidance and appendices compilation guidance documents for internal and external (e.g., CRO) use.

Ensures documents are compliant with NBI standards and procedures.  Ensures consistency in QC review across documents and programs.

Works closely with document authors and ensures compliance to related federal regulations and ICH guidelines.

Trains other QC personnel and provides additional training based upon QC findings.


Must have good verbal and written communication skills.

Previous QC review experience or familiarity with regulatory documents is preferred.

Must have strong attention to detail and be proficient in MS Word and Excel.  Experience with StartingPoint Templates is helpful.

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