Vertex Pharmaceuticals, Boston, MA (Contract)
- Perform quality control of GLP/nGLP Protocols, Reports, Amendments, Clinical Pathology Reports, IBs, Regulatory submissions/responses, ensuring compliance with regulatory standards and internal guidelines.
- Manage documentation archival to PSA Repository and Veeva Vault, maintaining accurate and organized records for regulatory submissions and internal reference.
- Handle contracting of outsourced nonclinical work, including consulting agreements and specific assay ordering (e.g., Safety-47, nGLP Genetox), ensuring timely project execution.
- Coordinate with PMs for regulatory submission activities including content plan development, management of documents in Veeva, formatting, and QC of nonclinical sections.
- Facilitate the review and approval workflows of Contract/Project Statement submissions for CROs.
- Perform program management activities, in collaboration with Toxicology, Pathology, DMPK, and BA, to support Vertex research and development goals.
- Manage and track various PSA activities using Smartsheet like QC tracker, Safety47 process.
- Assist in external Lab/CROs queries (e.g., sending COAs, creating and sending Vertex report numbers) to ensure timely and efficient execution of Non clinical studies.