Regulatory AI Medical Writer — Pharma Submissions Expert

OpenKrill; United States; Remote; USD 180.000 - 250.000; Vollzeit

Benefits dieser Stelle

Equity

Zusammenfassung

Edison Scientific is seeking a Regulatory Affairs/Medical Writer to join our Forward Deployed team on site with pharma and biotech partners. You will evaluate AI-assisted content, set benchmarks for quality, and coordinate with partner regulatory and medical writing teams to ensure submissions meet guidelines and standards.

You will guide the regulatory content integrity of AI outputs, understand agency expectations, and feed insights back to improve platform reasoning for regulatory documents

Qualifikationen

• 5+ years in Regulatory Affairs or Medical Writing in pharma/biotech
• Bachelor's degree required; advanced degree preferred (Ph.D./Pharm.D./M.D./M.S.)
• Familiarity with ICH guidelines and FDA/EMA expectations
• Experience authoring CTD modules, clinical study reports, investigator brochures, and briefing documents
• Experience with eCTD structure and end-to-end submission process (IND to NDA/BLA/MAA)
• Travel 20-40% of time

Aufgaben

• Evaluate and improve AI-generated regulatory and medical writing tasks (IND/NDA modules, clinical study reports, IBDs, briefing documents)
• Partner with client regulators and medical writers to ensure quality, accuracy and compliance for submissions
• Build benchmarks and acceptance criteria for regulatory writing-focused AI workflows
• Collaborate with regulatory professionals to deploy AI agents in document preparation workflows
• Act as regulatory content authority on AI outputs, assessing accuracy, compliance, and narrative quality
• Work with Forward Deployed Engineers to scope engagements and measure success

Kenntnisse

Regulatory Affairs

Medical Writing

ICH Guidelines

FDA/EMA standards

eCTD knowledge

Ausbildung

Bachelor's degree

Ph.D./Pharm.D./MD/MS preferred

Tools

Veeva Vault

Documentum

Jobbeschreibung

Edison Scientific is seeking a Regulatory Affairs/Medical Writer to join our Forward Deployed team on site with pharma and biotech partners. You will evaluate AI-assisted content, set benchmarks for quality, and coordinate with partner regulatory and medical writing teams to ensure submissions meet guidelines and standards.

You will guide the regulatory content integrity of AI outputs, understand agency expectations, and feed insights back to improve platform reasoning for regulatory documents