Forward-Deployed Regulatory Affairs/Medical Writer (AI)

Location: Remote available in the U.S. only; ideally based in San Francisco, Boston, or New York City. Onsite work with pharma and biotech partners and travel required 20–40% of the time.

Salary: $180,000–$250,000 per year, plus equity.

Company

Builds and deploys AI scientist agents to accelerate scientific research and the development of new medicines.

What you will do

• Evaluate and improve AI agent performance on regulatory and medical writing tasks, including IND and NDA modules, clinical study reports, investigator brochures, briefing documents, and responses to agency queries.
• Validate AI-generated regulatory documents with partner organizations against quality, accuracy, and compliance standards for health authority submissions.
• Build benchmarks and acceptance criteria for regulatory-writing agent workflows.
• Work with regulatory affairs professionals and medical writers to deploy AI agents into document preparation workflows.
• Assess scientific accuracy, guideline compliance, internal consistency, and narrative quality of AI-generated content.
• Collaborate with Forward Deployed Engineers and the Go-to-Market team on account delivery, engagement scoping, success metrics, and technical evaluations.

Requirements

• At least 5 years of experience in Regulatory Affairs or Medical Writing in the pharmaceutical or biotechnology industry, ideally at a sponsor organization.
• Bachelor’s degree required; an advanced life sciences degree such as a Ph.D., Pharm.D., M.D., or M.S. is preferred.
• Strong understanding of regulatory requirements, ICH guidelines, and FDA and EMA expectations.
• Hands-on experience authoring CTD module sections, clinical study reports, investigator brochures, and briefing documents across IND, NDA, BLA, and MAA submissions.
• Familiarity with eCTD structure, end-to-end submission processes, and regulatory information management systems such as Veeva Vault or Documentum.
• Ability to travel 20–40% of the time and work onsite with pharma and biotech partners.

Nice to have

• Experience in oncology, immuno-oncology, immunology, cardiovascular, neurology, or hepatology/MASH.
• Familiarity with AI-assisted writing or document automation tools.
• High comfort with ambiguity and fast iteration.

Culture & Benefits

• Mission-driven, fast-moving environment focused on applying AI to scientific research and medicine development.
• Full healthcare coverage, including 100% employer-paid premiums for employees and dependents.
• Paid parental leave, fertility coverage, new-parent support, and mental health services.
• 401(k) company matching, commuter benefits, and quarterly health and wellness support.
• Pet care stipend, meals in the office, and regular team off-sites and company events.