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Salary: USD 180,000 - 250,000 / annual
Edison Scientific is building AI scientist agents to accelerate drug development and the discovery of new medicines. The company combines expertise from leading researchers in biology, physics, chemistry, and AI to deploy intelligent systems that augment pharmaceutical R&D workflows.
You will join the Forward Deployed team as a Regulatory Affairs and Medical Writing specialist, embedded with pharma and biotech partners. Your core mission is to evaluate AI-generated regulatory content, establish quality benchmarks, and work directly with partner regulatory and medical writing teams to integrate AI agents into their document preparation processes across the submission lifecycle (IND through NDA/BLA/MAA).
Key responsibilities include:
- Evaluate and refine AI agent performance on regulatory and medical writing tasks, including IND and NDA module drafting, clinical study reports, investigator brochures, briefing documents, and agency query responses
- Partner with end-user regulatory affairs and medical writing teams at client organizations to validate that AI-generated documents meet quality, accuracy, and compliance standards for health authority submissions
- Build benchmarks and acceptance criteria for regulatory writing workflows powered by AI agents
- Deploy AI agents into partner document preparation workflows and provide ongoing support
- Serve as the regulatory content authority, assessing scientific accuracy, guideline compliance, internal consistency, and narrative quality of AI outputs
- Collaborate daily with Forward Deployed Engineers on each account, supporting engagement scoping, success metrics, and technical evaluation with the Go-to-Market team
- Travel 20–40% to partner sites
This is embedded, partner-facing work requiring you to build credibility with regulatory and clinical teams, understand their writing conventions and agency expectations, and feed insights back to the AI team to improve how the platform reasons about regulatory content, structure, and scientific argumentation.
REQUIREMENTS:
- 5+ years of experience in Regulatory Affairs or Medical Writing within pharmaceutical or biotechnology industry, ideally at a sponsor organization
- Bachelor's degree required; advanced degree preferred (Ph.D., Pharm.D., M.D., or M.S. in life sciences)
- Strong understanding of regulatory requirements and familiarity with ICH guidelines and FDA/EMA expectations
- Hands-on experience authoring regulatory documents such as CTD module sections, clinical study reports, investigator brochures, and briefing documents, with exposure across IND through commercial submissions (NDA, BLA, MAA)
- Familiarity with eCTD structure and end-to-end submission process from authoring through publishing
- Experience in therapeutic areas such as oncology, immuno-oncology, immunology, cardiovascular, neurology, or hepatology (MASH) preferred
- Experience with regulatory information management systems such as Veeva Vault or Documentum
- Ability to travel 20–40% of the time
PREFERRED:
- Familiarity with AI-assisted writing or document automation tools
- High comfort with ambiguity and fast iteration
