Avalere’s FDA Fellowship Program is small and highly selective. As an FDA Fellow, participants will spend six (6) months immersed in health and life science regulatory policy and strategy issues to help support the efforts of Avalere’s clients that include FDA-related issues. This position is a full-time, paid fellowship ($25/hour), and Fellows will collaborate within our existing FDA team to increase Avalere’s presence and visibility as experts and thought-leaders in the FDA space. Fellows may also be given the opportunity to help integrate this FDA regulatory policy effort within Avalere’s health policy and commercialization spaces, as well as contribute to health economics and outcomes work we are undertaking.

Topics of current interest and importance include, but are not limited to: opportunities for improved regulatory efficiency during development and review,  impact of post-market surveillance on market access and reimbursement for new technologies; implementation of a pathway for biosimilars and the associated life cycle management questions for originator biologics; regulation of devices and diagnostics; effective implementation of user fees; and patient engagement initiatives; international harmonization of regulatory requirements for all medicines We prize intellectual curiosity, creativity, and mental flexibility. While current expertise in a pertinent topic is a plus, none is essential.

This is a challenging and rewarding opportunity for life sciences professionals, who are transitioning into industry, the public sector, or consulting, to gain valuable knowledge of regulatory issues facing healthcare companies and associated considerations during research and development. Through the Fellowship, participants will develop the ability to frame issues and guide clients with their strategic policy responses. Career guidance and mentorship are built into the Fellowship, in addition to guidance on networking and career transitioning. The Fellowship is designed to provide relevant and recognized healthcare policy experience at a top tier firm.

The appropriate candidate should have:

• A doctoral level degree (PhD, ScD, MD, DVM, etc.) in one of the following disciplines:
  • Medical and Health Sciences
  • Biological, Chemical, Physical, or Earth Sciences
  • Social and Behavioral Sciences
  • Computational or Statistical Sciences and Mathematics
• The following degrees with a strong background in science and technology will also be considered:
  • Juris Doctorate
  • Master in Public Health or Public Policy
• Excellent oral and written communication skills
• Broad interests in health care and a natural curiosity
• Previous consulting experience (preferred, but not necessary)

For more information https://careers-avalere.icims.com/jobs/8721/fellow%2c-fda-%26-regulatory-policy/job?mobile=false&width=1230&height=500&bga=true&needsRedirect=false&jan1offset=-360&jun1offset=-300