Associate Medical Director, Medical Quality Assurance - Remote

Overview

The Medical Quality Assurance Physician plays a critical role in ensuring patient safety and product effectiveness within a pharmaceutical setting. This multifaceted position involves collaboration with the Product Safety Team to author and approve Health Hazard Assessments and Medical Opinions concerning potential product-related issues. The Medical Quality Assurance Physician is essential for maintaining high standards of product quality and safety, protecting patient well-being across all stages of product lifecycles.

In Short

• Design product life cycle strategy based on medical knowledge.
• Support development and maintenance of device/combination products.
• Design product-use risk assessment tools.
• Review significant product changes for patient safety impact.
• Develop thresholds for product complaints for effective monitoring.
• Review and approve product complaints with medical assessments.
• Interface with Pharmacovigilance and Clinical Development teams.
• Approval of Health Hazard Assessments and Medical Opinions.
• Participate in Triage Committee for manufacturing events.
• Ensure compliance with high impact quality issues affecting product safety.

Requirements

• M.D. or equivalent (D.O., M.B.B.S, etc.) required.
• Board certification preferred with diverse clinical experience.
• 0-5 years in drug risk management or medical device vigilance.
• Track record in managing product safety matters preferred.
• Experience in clinical and medical device development processes.
• Basic expertise in clinical, drug, and medical device development.
• Strong organizational and prioritization skills.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance available.
• 401(k) plan for eligible employees.
• Participation in short-term and long-term incentive programs.