Opioid BE & Safety Regulatory Fellowship

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

FDA/CDER invites an ORISE fellow to contribute to regulatory science research at the FDA in Silver Spring, MD, under an ORISE fellowship. You will study bioequivalence and food effects for IR opioid generics, and analyze ANDA data to understand variability in systemic exposure.

The program emphasizes dissolution methods, literature evaluation, and data interpretation, with mentorship and a one-year, full-time appointment. This opportunity includes a stipend commensurate with experience.

Qualifications

• BE principles and food effect assessment
• Dissolution science concepts and regulatory BE guidance
• Literature reviews and interpretation in regulatory science

Responsibilities

• Learn BE concepts and food effects for IR opioid generics.
• Analyze ANDA data to assess variability in BE.
• Apply biostatistical methods to regulatory research questions.
• Communicate findings to multidisciplinary teams.

Skills

BE principles

Data analysis

Biostatistics

Dissolution science

Regulatory science

Scientific writing

Education

Doctoral degree (PhD/ PharmD)

Job description

FDA/CDER invites an ORISE fellow to contribute to regulatory science research at the FDA in Silver Spring, MD, under an ORISE fellowship. You will study bioequivalence and food effects for IR opioid generics, and analyze ANDA data to understand variability in systemic exposure.

The program emphasizes dissolution methods, literature evaluation, and data interpretation, with mentorship and a one-year, full-time appointment. This opportunity includes a stipend commensurate with experience.