Contractor, Using AI to Improve FDA Transparency

1Day Sooner

📍Remote (Global) 💰$60 USD/hour
💼 Contract 🔄 Rolling Applications

1Day Sooner is seeking a contractor to support our regulatory portfolio, which focuses on increasing transparency at the Food and Drug Administration (FDA) to accelerate biomedical research and development (R&D).

One of our key recommendations is that the FDA should publish more documents about the products it regulates, particularly Complete Response Letters (CRLs). CRLs are formal letters that the FDA sends to drug companies explaining why a product has not been approved. Publishing these letters would provide valuable insight to researchers, patients, and the public. However, a major barrier to publication is the need for redactions. CRLs often contain trade secrets or confidential information, and current redaction processes require extensive manual review. We believe artificial intelligence (AI) could help automate this process, enabling real-time publication of CRLs while protecting sensitive information.

We are hiring a contractor to research and produce a detailed (~5,000 word) report on how the FDA could use AI to support CRL redaction and publication. The report should:

• Assess the legal and regulatory challenges, including issues related to confidential information and trade secrets.

• Outline technical approaches for applying AI to redaction.

• Recommend strategies to balance transparency with legal compliance.

This project will provide a practical roadmap for how the FDA might responsibly adopt AI to improve transparency and accelerate biomedical progress.

Key Information

• Apply by filling out the Airtable form here.  (The review of applications is underway and will continue until the position is filled.)

• Details about the role:

  • Contractor (Independent/1099)

  • Remote position (1Day has no offices, and this work can be done from anywhere)

  • The position will report to the U.S. Advocacy Director at 1Day Sooner.

  • Compensation: Starting at $60/hour, with upward adjustments for relevant terminal degrees or experience.

• If the contract period is successful and the report gains policy momentum, the contractor may have the opportunity to transition into a permanent role at 1Day Sooner.

Position Responsibilities

• Lead the development of a ~5,000-word report with actionable recommendations for how the FDA could use artificial intelligence (AI) to automate the redaction of Complete Response Letters (CRLs) and other regulatory documents.

• Provide a comprehensive analysis of the legal considerations, including issues related to trade secrets, confidential information, and regulatory constraints.

• Provide a thorough review of the technical considerations, including current AI methods and their applicability to document redaction.

• Develop a clear, step-by-step roadmap for how the FDA could implement AI redaction in practice, balancing transparency with legal compliance.

• Ensure the report is accessible to both technical and policy audiences, offering practical recommendations that can inform real-world adoption.

What We’re Looking For

The ideal candidate will have the following traits and abilities:

• Mission-driven: You are excited about 1Day’s mission and principles. You do not have to be well-versed in things like human challenge studies, but we expect someone who is passionate about reducing the burden and threat of infectious diseases worldwide.

• Relevant experience (each desirable but not strictly necessary): 

  • Strong ability to conduct self-directed research and synthesize findings into clear recommendations.

  • Experience writing clear, well-structured technical reports for a broad audience.

  • Legal training or demonstrated familiarity with FDA regulations and processes.

  • Understanding of artificial intelligence (AI) applications, particularly in document processing or regulatory contexts.

If this sounds like you, please apply now!