Regulatory Analyst II - Remote

Overview

The Regulatory Analyst II position at the University of Miami involves overseeing regulatory submissions and ensuring compliance with applicable regulations throughout the study lifecycle.

In Short

• Review and prepare regulatory submissions for clinical trials.
• Maintain regulatory documents to ensure compliance.
• Act as a point of contact for boards and sponsors.
• Assist in drafting and presenting compliance programs.
• Stay updated on regulatory topics and institutional policies.
• Ensure adherence to federal and institutional regulations.
• Work collaboratively with research staff and stakeholders.
• Utilize sound judgment and problem-solving skills.
• Organize and analyze data effectively.
• Demonstrate excellent time-management and prioritization skills.

Requirements

• Bachelor's Degree in a relevant field.
• Minimum two years of experience in compliance or medical/clinical fields.
• Preferred experience with IND/IDE/FDA regulations.
• Strong communication skills, both oral and written.
• Detail-oriented and highly organized.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Ability to work under pressure and meet deadlines.
• Knowledge of clinical trial processes.
• Ability to maintain effective relationships with diverse teams.
• Sound judgment and decision-making capabilities.

Benefits

• Competitive salary and comprehensive benefits package.
• Medical and dental coverage.
• Tuition remission for employees.
• Opportunities for professional development.
• Supportive and diverse work environment.
• Access to cutting-edge research and medical education.
• Participation in a vibrant academic community.
• Work with leading specialists in various fields.
• Contribution to impactful healthcare initiatives.
• Commitment to fostering a culture of belonging.