Regulatory AI Medical Writer — Submissions & Partnerships

OpenKrill; United States; Remote; USD 180,000 - 250,000; Full time

Benefits offered by this job

Equity

Full healthcare coverage

Parental leave

Fertility coverage

Mental health support

401(k) matching

Wellness benefit

Commuter benefits

Lunch provided

Job summary

Edison Scientific is seeking a Regulatory Affairs/Medical Writer to join our Forward Deployed team onsite with pharma and biotech partners. You will evaluate AI-generated regulatory content, ensure submission readiness, and collaborate with client regulatory and medical writing teams to improve document quality and compliance.

Ideal candidates have 5+ years in Regulatory Affairs or Medical Writing in pharma/biotech, a life sciences degree, familiarity with ICH/FDA/EMA guidelines, and experience

Qualifications

• 5+ years in Regulatory Affairs or Medical Writing within pharma/biotech.
• Bachelor's degree required; advanced degree preferred (PhD/PharmD/MD/MS).
• Strong regulatory knowledge and agency expectations (ICH, FDA, EMA).
• Hands-on authoring of regulatory documents (CTD, clinical study reports, BRs).
• Familiarity with eCTD structure and end-to-end submissions.

Responsibilities

• Evaluate and improve AI-assisted regulatory writing tasks for IND/NDA modules.
• Collaborate with client regulatory and medical writing teams to ensure submission readiness.
• Build benchmarks and acceptance criteria for regulatory writing workflows.
• Deploy AI agents into document preparation workflows with regulatory professionals.
• Act as regulatory content authority on AI outputs ensuring accuracy and compliance.
• Collaborate with Forward Deployed Engineers and Go-to-Market teams for engagement scoping.

Skills

Regulatory affairs experience

Medical writing

ICH guidelines knowledge

FDA/EMA familiarity

CTD/eCTD experience

Travel willingness

AI-assisted writing familiarity

Education

Bachelor's degree in life sciences

PhD/PharmD/MD or MS preferred

Tools

Veeva Vault

Documentum

Job description

Edison Scientific is seeking a Regulatory Affairs/Medical Writer to join our Forward Deployed team onsite with pharma and biotech partners. You will evaluate AI-generated regulatory content, ensure submission readiness, and collaborate with client regulatory and medical writing teams to improve document quality and compliance.

Ideal candidates have 5+ years in Regulatory Affairs or Medical Writing in pharma/biotech, a life sciences degree, familiarity with ICH/FDA/EMA guidelines, and experience