Medical Affairs Governance

Description:

The Associate Director – Governance, Risk and Control will lead the regulatory (e.g., GxP, Data Integrity, etc.) quality oversight program for 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 Medical functions. This role will engage across all functions of Medical and the Company including global and affiliate personnel, Global Patient Safety, R&D Quality, and R&D Audit to effectively promote consistent and coordinated quality execution.

You will be responsible for:
Development, implementation, and continual improvement of medical’s quality program as it pertains to regulatory quality, including risk assessment, governance, monitoring, reporting, oversight to audit/inspection readiness and remediation.

Representing Medical Affairs in company regulatory quality forums (e.g., inspection preparation teams), and ensure cohesive inclusion of Medical with related Company functions and processes (e.g., Global Patient Safety, Regulatory, R&D Quality).

Creating awareness and buy-in at all functions and levels of Medical on regulatory process and quality management concepts, best practices, and strategic relevance.

Identifying opportunities for collaboration and foster communication within and outside of Medical to enable alignment on quality initiatives at the global and local levels and across functions.

Providing guidance and collaborate with Process Owners and Subject Matter Experts in the development and maintenance of regulatory quality related processes and relevant risk management initiatives.

Ensuring, in coordination with related stakeholders, robust GxP and regulatory quality training for appropriate medical functions.

Engaging as a leader on Medical Affairs Governance, Risk and Controls initiatives, including Annual Risk Assessment.

Leading strategy and execution of regulatory quality monitoring across Medical Affairs, on a risk-based methodology to be developed, to ensure adherence to quality expectations.

Implementing and managing tools to track and report key quality metrics.

Overseeing issue management including, root cause analysis, resolution design, timelines of implementation, effectiveness check, etc., and determine whether to escalate to R&D Quality.

Communicating and influence at all levels of the organization.