Health Regulatory Specialist
FAS is seeking to hire a Health Regulatory Specialist to support our dynamic and growing health equity portfolio. FAS works hand in hand with policymakers from across the federal government to develop and support policies and programs aimed at rapidly accelerating equitable medical products broadly accessible to patients across the United States. FAS serves as a convener of ideas and stakeholders across the medical innovation pipeline from basic research to translational science to regulatory policy to post-market evaluation.
Medical products, such as drugs and devices, are a part of every patient’s care. Yet, many of the crucial decisions about the efficacy, safety, affordability, and equitable design of medical products are being made solely between the FDA and its sponsors. FAS believes that expanding the scope of actors with a stake in medical products regulation – other federal agencies, the academic community, the patient and caregiver community, and the broad public – will improve overall patient care. For this reason, it is essential to create a nimble, participatory, and transparent process to regulate products that benefit the health of all Americans.
In a time of ever-growing complexity for regulatory decision making, FAS is preparing to re-envision how the Food and Drug Administration (FDA) engages external experts through its Federal Advisory Committees (FAC) and other public engagement mechanisms. In your role as a health policy specialist, you will support FAS as it seeks to crowdsource reform proposals for public engagement in regulatory review and then activate the implementation of these policy reforms by directly engaging a network of policy actors within the FDA, other federal agencies, Congress, and external organizations poised to drive evidence-based policymaking at the frontiers of regulatory science (i.e. equitable design, clinical trial innovation, accelerated approvals, complex generics and drug repurposing, AI/ML, etc). We seek an entrepreneurial, resourceful policy enthusiast to join our ranks as a health policy specialist.
At the Federation of American Scientists, we believe in embracing a growth oriented and entrepreneurial mindset to drive impact for our colleagues, our customers and the world. The right candidate will help shape the role according to their skills, and act as a key player toward achieving significant growth and long-term sustainability for The Federation of American Scientists.
What you’ll do (Core responsibilities)
- Engage in policy research and provide subject matter expertise on topics related to science advice structures (federal advisory committees), participatory policymaking, regulatory decision making at the FDA, and emerging topics of regulatory concern at the frontiers of regulatory science (AI/ML, complex generics, clinical trial innovation accelerated approvals, health equity).
- Coordinate and conduct a series of interviews and focus groups with stakeholders in the regulatory decision making process (FAC committee members, FDA Center Directors, Designated Federal Officers, FDA leadership)
- Liaise and coordinate between existing federal partners and external organizations to support ideation and engagement within FAS’ work on FDA regulatory decision making and equitable medical device development practices.
- Develop reports, briefs, and memos for guiding the FDA and other federal agencies to cultivate a more inclusive, evidence-driven, participatory regulatory decision making process.
- Support and help lead the day-to-day work and coordinating activities across the FAS teams to support the advancement of existing and new projects and strategic areas of focus for our growing health equity portfolio.
Skills and Experience (Requirements)
- 3 to 6 years of professional experience working in the private sector, government, academia, research organizations, or related areas.
- An understanding of the landscape and players in the U.S. federal health research and development ecosystem
- An understanding of U.S. regulatory policy for medical products (drugs, devices, and algorithms) and the existing challenges in accelerating innovations to market, addressing issues of diversity in clinical trials, and ensuring equity in product design. This can be shown through relevant coursework, research products (presentations and papers), or written policy briefs.
- Experience in qualitative research methods, such as surveys, interviews, and focus groups.
- Experience in project management and overseeing specific project activities through to implementation.
- Exceptional face-to-face, phone, and written communication skills, including the ability to compellingly articulate FAS’s mission to a variety of different audiences.
- Motivated self-starter who values learning; contributes as part of a team and thrives in a collaborative environment.
- Ability to work independently, set priorities and handle multiple issues at the same time.
- Ability to manage relationships with a range of stakeholders inside and outside of government.
- Excellent writing skills
Nice to haves
- A Masters of Public Health or related degree
- Experience working in the clinical research ecosystem, such as on clinical trials
- Experience working in the field of regulatory science
- Experience in quantitative research, analytics and data modeling.
- Demonstrated knowledge and direct experience working in different sectors (e.g. government, private sector, nonprofits, etc.)
This position will be a hybrid role, meaning that both remote and in-person work can be accommodated, generally two to three days per week on-site, and two to three days per week remote.
$70,000 – $105,000; This position will be a term position, for an initial period of 12 months, with renewal contingent on funding.