Rackner is hiring a
Program Manager Sr. in Worldwide

Summary

The job involves providing new programs for the generation and analysis of clinical evidence used in regulatory decision-making of medical devices. This role requires conducting novel research, developing advanced data analysis tools using AI/ML, and supporting scientific workload needs. The position is remote and requires Public Trust Eligibility clearance.

Requirements

• Master’s degree or higher in Epidemiology, Public Health, Biostatistics, Medicine, Biomedical Engineering, or related field
• 5 years; Real-world evidence (RWE) research, with a focus on healthcare outcomes or medical devices
• Data analysis and interpretations
• Knowledge of regulatory requirements and guidelines related to RWE in the medical device industry
• Lead and mentor a team, managing resources effectively to meet project deadlines and objectives
• Present complex RWE and concepts to a variety of stakeholders
• Professional experience with RWE methodologies including study designs, patient registries, electronic health records and claims database analyses
• Manage large-scale RWE projects, from conception through to execution and dissemination

Responsibilities

• Provide new programs and enhance existing programs for the generation and analysis of clinical evidence used in regulatory decision-making of medical devices
• Conduct novel research
• Develop advanced data analysis tools using state-of-the-art AI/ML
• Support scientific workload needs
• Conduct Clinical Evidence Studies
• Perform Systematic Literature Review (SLR)
• Perform Performance Tracking of Regulatory Programs
• Provide Clinical Evidence Research and Surge Support

Preferred Qualifications

• Statistical software tools like SAS, R or Python
• PhD or MD

Benefits

• Rackner embraces and promotes employee development and training and covers the cost of certifications relevant to a position and the technologies/services provided
• Fitness/Gym membership eligibility
• Weekly pay schedule and employee swag, snacks & events are offered as well!
• 401K with 100% matching up to 6%
• Highly competitive PTO
• Great health insurance with large network of providers
• Medical/Dental/Vision
• Life Insurance, and short & long term disability