The role focuses on clinical trial site management and monitoring activities in compliance with GCP guidelines and SOPs. Key tasks include executing qualification, initiation, routine, and close-out visits while maintaining trial master files.
Immatics
8 Remote Job Openings at Immatics
Senior Director Regulatory Affairs, Advertising & Promotion
Immatics
·
Full Time
·
20 days ago
Immatics
Serve as the primary U.S. regulatory expert for promotional materials and lead the Promotional Review Committee (PRC) to ensure compliance with FDA and OPDP guidelines. Manage labeling negotiations, file pre-clearance materials, and oversee the regulatory strategy for commercial launches.
Serve as the EU Submission Lead for clinical trials, managing the preparation and submission of applications via CTIS. Coordinate regulatory activities with cross-functional teams and external vendors to ensure compliance and timely delivery of application packages.
The Senior CRA oversees clinical trial site management and monitoring activities to ensure compliance with ICH-GCP and regulatory standards. Key duties include conducting site visits, managing patient recruitment, and mentoring junior CRA team members.
Lead the GCP-compliant planning and execution of clinical studies, including managing budgets, timelines, and outsourced vendor activities. Provide operational support for central laboratories and mentor junior Clinical Operations Leads.
The Clinical Trial Manager oversees site management, monitoring oversight, and operational activities to ensure compliance with GCP and regulatory requirements. They partner with leadership to drive study execution, manage site engagement, and provide guidance to CRAs.
You will lead EU regulatory strategy for oncology biopharmaceutical programs from early development through marketing authorization. This includes managing health authority interactions, clinical trial applications, and ensuring regulatory compliance across cross-functional teams.
The Director of Medical Communications will lead global medical publication planning, congress strategy, and scientific dissemination for priority programs. They are responsible for developing the scientific platform, managing vendor execution, and ensuring consistent, compliant communication of clinical data.
