Medical Affairs Governance, Risk and Control

Overview

This is what you will do:

The Associate Director – Governance, Risk and Control will lead the regulatory (e.g., GxP, Data Integrity, etc.) quality oversight program for Alexion Global Medical Affairs. This position will provide direction and oversight to the strategy, planning, management, and execution of all regulatory quality risk management and mitigation activities within Global Medical Affairs. This role will engage across functions of Medical and the Company including Global Patient Safety, R&D Quality, and R&D Audit to effectively promote consistent and coordinated quality execution.

Responsibilities

• Development, implementation, and continual improvement of Global Medical Affairs’ quality program as it pertains to regulatory quality, including risk assessment, governance, monitoring, reporting, oversight to audit/inspection readiness and remediation.
• Represent Global Medical Affairs in company regu...