Associate Director, Medical Affairs Governance at Jobgether – United States
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About This Position
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Associate Director, Medical Affairs Governance in the United States.
This is a strategic leadership role focused on strengthening governance, compliance, and operational excellence across Medical Affairs. You will design and oversee global governance frameworks, ensuring alignment with regulatory standards and internal policies. The position sits at the intersection of science, compliance, and operations, requiring close collaboration with cross-functional stakeholders across regions. You will lead initiatives related to medical review processes, SOP development, and inspection readiness while driving continuous improvement. This role offers the opportunity to influence global medical strategy and ensure high standards across all activities. It is ideal for a seasoned professional who thrives in complex, regulated environments and is passionate about enabling compliant, high-impact medical operations.
- Lead the development and implementation of global Medical Affairs governance frameworks and processes
- Oversee Medical Review Committees (MRCs) and ensure compliant review of scientific materials and communications
- Establish and maintain SOPs, work instructions, and best practices to drive consistency and operational excellence
- Partner with Legal, Compliance, Regulatory, and QA teams to ensure adherence to global regulations and internal policies
- Drive inspection readiness efforts, including audit preparation, risk identification, and CAPA implementation
- Provide strategic guidance to leadership on governance, compliance risks, and process improvements
- Ensure alignment of medical activities with regulatory standards such as FDA, EMA, ICH, and industry codes
- Act as a key liaison across functions to harmonize governance practices globally
- Advanced degree (PhD, PharmD, MD) preferred; MS or equivalent experience in a related field considered
- 10+ years of experience in Medical Affairs, Medical Operations, Compliance, or Regulatory roles within biotech or pharmaceutical environments
- Strong expertise in global medical governance frameworks, SOP development, and compliance practices
- Deep knowledge of regulatory requirements (FDA, EMA, ICH, GVP, and industry standards)
- Proven experience supporting audits, inspections, and maintaining inspection readiness
- Experience leading Medical Review Committees or similar governance structures
- Excellent communication, leadership, and stakeholder management skills
- Ability to navigate complex regulatory environments and influence cross-functional teams
- Experience in oncology or precision medicine is a plus
- Competitive base salary range: $177,000 – $221,000 USD
- Equity compensation and performance-based incentives
- Comprehensive health, dental, and vision insurance
- Generous paid time off and flexible work arrangements
- Opportunities for professional development and continuous learning
- Inclusive, collaborative, and mission-driven work environment
- Access to wellness programs and employee support resources