Compassionate Use Program Coordinator

hace 2 semanas


Barcelona, Barcelona, España Syneos - Clinical And Corporate - Prod A tiempo completo

Key Responsibilities

As a Compassionate Use Program Coordinator at Syneos Health, you will play a critical role in supporting the planning and execution of Pre-Approval Access (PAA) Programs. Your primary focus will be on ensuring requests are processed with quality, speed, compliance, and in support of company objectives.

Core Job Responsibilities
• Execute triage, tracking, delivery of product and oversight elements of Pre-Approval Access Programs in compliance with quality standards (Global Regulations and the client policies and procedures).
• Support development with initiating Pre-Approval Access Programs.
• Work cross-functionally with Clinical Drug Supply, Clinical Documentation Center, Affiliates, etc. to ensure timely and compliant drug release to support PAA program decisions.

Reporting and Updates
• Responsible for regular updates to Manager on all assigned PAA Programs.
• Responsible for regular updates to the cross-functional teams (e.g., R&D Therapeutic Areas) and stakeholders (e.g., CDSM) on number of active patients and program status.
• Ensures Knowledge Notebook is accurate and current.

Rave Database Support
• Support the development of the Rave Database for PAA Programs.



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