Job Summary

A healthcare company is seeking a Telecommute FDA REMS Regulatory Manager in Scottsdale.

Must be able to:

• Contribute to most appropriate FDA submission or Assessment metric design
• Provide a strategy to deliver comprehensive, high-quality consulting deliverables
• Adhere to Quality Management standards and processes

Skills and Requirements Include:

• Must be able to travel 25%
• MS preferred or 4-year degree or equivalent experience
• 5+ years of related experience
• Knowledge of Risk Evaluation Mitigation Strategies (REMS), Pharmacovigilance/Drug Safety, Regulatory Affairs, Clinical Research, and/or Health Economics Outcomes Research (HEOR)
• Previous experience with authoring/drafting submission documents and assessment reports; analyzing data to access effectiveness of Programs
• 3+ years of experience working in a FDA-regulated environment
• Working knowledge of regulatory affairs, FDA regulations