Our client is looking to add a strategic partner to their mission-oriented team via a Director of Medical Governance, Monitoring, & Quality Assurance. This team is making long lasting impact on their therapy landscape, and looking for someone to contribute to that culture. This individual will have a wide range of responsibilities, including:
- Maintaining a robust governance framework and managing evolving policies and risk mitigation plans.
- Being accountable for risk monitoring, quality documentation & reporting, and audit administration for North American Medical Affairs.
- Collaborating with Global Medical Governance, US Legal and Compliance, and North American Medical Affairs leadership to align on and develop control and guidance documents.
- Overseeing the risk management of the organization's Medical Affairs Practices.
- Creating, developing, evolving, and maintaining North American/US specific policies and standard operating procedures.
- Guiding and serving as a resource for the Medical Affairs team with internal and external audits.
- Building communication strategies and managing implementation related to performance, audit findings/output, and activities for the Medical Affairs team.
- Revising and maintaining document control protocols.
- Driving development and embedding controls within Medical Affairs.
- Monitoring medical affairs activities and ensuring compliance with governance principles.
- Implementing and overseeing monitoring requirements related to evaluating medical responses to healthcare providers' (HCPs) inquiries.
- Leading and providing oversight to critical processes and programs for US Medical Affairs.
- Evaluating, driving, and refining continuous quality improvement to processes and programs for Medical Affairs.
- Educating and providing guidance on policies/regulations to all levels of Medical Affairs.
- Serving as the Medical Governance point of contact for Global and US Governance Teams.
- Serving as the Point of Accountability for US Medical Affairs with Compliance & Audit Teams.
Qualifications
- 5 years of Pharmaceutical experience
- 3 years of US compliance, monitoring, governance experience
- Experience developing and implementing compliance & risk management frameworks
- Audit and compliance experience including managing audit findings (i.e., CAPAs)
This role is crucial in ensuring the adherence to quality and compliance for the Medical Affairs team. It requires a strong understanding of medical governance, risk management, and quality assurance. The individual in this role will need to be highly organized, detail-oriented, and capable of managing multiple complex tasks simultaneously. They will also need to have excellent communication skills to effectively collaborate with various internal stakeholders and teams.
If interested, don't hesitate to apply!
