FDA Fellow

Summary

Join Avalere Health's FDA Fellowship Program, a 6-month, fully remote, paid fellowship (with hybrid options in D.C. or NYC), offering valuable knowledge of regulatory issues in healthcare. The program focuses on product development, FDA review criteria, approval pathways, and market access. Fellows will develop strategic planning skills, conduct research, present on regulatory topics, and contribute to publications. The program is highly selective and may lead to a permanent role. Successful candidates will possess a strong scientific background and advanced degree.

Requirements

• Demonstrated scientific background/prior experience in at least one of the following
• Biological, chemical, or physical sciences
• Computational or statistical sciences
• Government, legal, or public policy disciplines
• Completed MS or PhD in physical science (e.g., Biology, Chemistry, Pharmacology) or in applied science (e.g., Biotechnology), or PharmD, or Juris Doctor, or MA in Public Policy or Public Health
• Demonstrated strength in verbal and written communication and translation of analytical information
• Ability to analyze data and/or information in Microsoft Office Suite, including Excel and PowerPoint
• Strong intellectual curiosity and comfortability with uncertainty

Responsibilities

• Gain valuable knowledge of regulatory issues facing healthcare companies
• Topic areas of focus include product development (e.g., clinical trial design strategy), non-clinical and clinical review criteria by FDA, approval pathways, market exclusivity terms, legislative and regulatory policy assessments
• Develop the ability to frame issues and guide clients with their strategic planning
• Research regulatory policy topics and follow current events related to the FDA
• Present on regulatory topics related to drugs, biologics and medical devices internally and externally
• Write and contribute to Insights, published on the Avalere Health website. on regulatory science and policy subjects
• Utilize quantitative and qualitative analytical skills to conduct research for clients
• Integrate FDA policy and strategy learnings within the broader range of market access and commercialization considerations relevant to clients

Preferred Qualifications

Previous consulting or industry experience

Benefits

• Full-time, paid fellowship ($37,500 for 6-month program)
• PTO, Holiday Pay
• Health Insurance
• 401K