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