Associate Director/Sr. Manager, Clinical and Regulatory Document Quality Control

Summary

The Associate Director/Sr. Manager, Clinical and Regulatory Document Quality Control (cQC) will review near-final clinical and regulatory documents to ensure accuracy, internal consistency (including overall messaging), adherence to company standards, compliance with regulatory guidance, and oversight of all external QC collaborators.

Responsibilities

• Review clinical and regulatory documents including clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures, Statistical Analysis Plans, Development Safety Update Reports, and clinical summaries for CTD submissions.
• Verify documents for accuracy against source data. Ensure internal consistency and correct grammar, punctuation, and style.
• Help develop a formal QC process for a variety of clinical and regulatory documents including SOPs and Wis, as needed.
• Manage all QC related projects in an organized manner including overseeing all external QC resources.

Qualifications

• BA/BS in a science-related discipline and 4+ years of relevant QC experience with clinical and regulatory documents
• Excellent verbal communication and technical writing skills
• In-depth knowledge of industry regulations, guidance’s, and regulatory documentation requirements. Must be able to effectively understand, interpret, and apply company standards and regulatory guidance to all documents reviewed.
• High degree of focus and consistent attention to detail is required.
• Experience interacting and communicating timeline expectations with cross functional study team members
• Expert/highly proficient in the functionality of MS Word
• Experience with electronic document management systems (e.g., Veeva Vault)