Theradex Oncology

The associate serves as the primary contact for study sites during start-up, managing regulatory tasks and ensuring compliance with FDA regulations. Responsibilities include reviewing informed consent forms, maintaining the eTMF, and tracking study deliverables from start-up through closeout.

The role involves leading the end-to-end delivery of IT projects, balancing technical analysis (60%) and project management (40%). Key duties include defining project scope, analyzing business requirements, and performing detailed data reviews to build innovative IT solutions.

The Senior Medical Writer is responsible for preparing critical regulatory documents including IND applications, clinical study protocols, and investigator's brochures for oncology trials. The role involves collaborating directly with clients, medical monitors, and senior leadership to manage document timelines and review cycles.

The Head of Regulatory Affairs will develop and execute regulatory strategies to ensure timely approvals and lifecycle management for oncology trials. They will also lead and develop the regulatory team while serving as a key liaison for multi-continental projects.