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Prepare and author regulatory and clinical trial documentation (INDs, NDA/BLA, briefing books, pediatric plans, orphan/fast track/breakthrough submissions). Provide regulatory consulting and project management across all drug development phases, interpret regulatory feedback, advise teams, and support 505(b)(2) pathway submissions while identifying scope changes and business opportunities.

The Clinical Enrollment Coordinator ensures the safe enrollment of study participants, manages project timelines, and maintains quality control of documentation.

The Executive Director leads technology and data functions for Clinical Operations, ensuring system reliability, data flow, and process optimization to enhance study execution and operational efficiency.

The Executive Director leads technology and data initiatives for Site & Study Startup, enhancing operational efficiency and compliance in clinical trials.

The Vice President, AI Enablement will drive AI strategy and implementation across Parexel, ensuring AI governance, compliance, and integration with business functions, while leading a team of AI professionals.

The Global Procurement Manager leads procurement operations, managing contracts and supplier relationships, while ensuring service quality and compliance in cross-functional teams.

The Senior Clinical Research Associate oversees site management and monitoring for clinical trials, ensuring compliance with GCP, patient safety, and quality execution of studies. Responsibilities include managing operational aspects, training site personnel, addressing protocol issues, and conducting monitoring activities.

Lead statistical programming efforts for global studies, ensuring quality deliverables and compliance with regulations while mentoring team members and managing projects.

Responsible for managing and negotiating contracts for clinical trials, including review of CDAs, CTAs, and ICFs, while ensuring compliance and operational efficiency.

The Labeling Strategist will lead the development of global labeling strategies, manage labeling documents, and ensure compliance with regulations while collaborating with cross-functional teams.