Regulatory Analyst 1 - Remote

University of Miami

Miami, FL, US
Not specified; not specified; comprehensive benefi...
Fully remote
Bachelor's degree in relevant field
Minimum 1 year of relevant experience
Knowledge of federal regulations and university policies
The Regulatory Analyst 1 will analyze claims data to identify possible cancers and ensure compliance with federal regulations

Job Summary

  • The Regulatory Analyst 1 will analyze claims data to identify possible cancers and ensure compliance with federal regulations.
  • This role involves reviewing protocol packages, modifying consent forms for IRB submission, and assisting with IND filings to the FDA.
  • The University of Miami offers a competitive salary and comprehensive benefits package including medical, dental, and tuition remission.

Matching Summary

The Regulatory Analyst 1 will analyze claims data to identify possible cancers and ensure compliance with federal regulations.

Salary

Not specified; Not specified; Comprehensive benefits including medical, dental, tuition remission

Skills & Requirements

Must-have

  • Bachelor's degree in relevant field
  • Minimum 1 year of relevant experience
  • Knowledge of federal regulations and University policies
  • Ability to handle difficult and stressful situations
  • Effective oral and written communication skills

Nice-to-have

  • Experience with FDA Form 1572 submissions
  • Familiarity with CTMS systems and Trial Master Files
  • Ability to build working relationships with regulatory staff
  • Proficiency in creating SOPs and training presentations

Key Requirements

  • Bachelor's degree required
  • Minimum 1 year relevant experience
  • Understanding of FDA, NIH, and HIPAA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter