Forward-Deployed Regulatory Medical Writer—Remote/Travel

Edison Scientific, Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive salary & equity

Full healthcare coverage

Parental leave program

Mental health support

Job summary

Edison Scientific, Inc. is seeking a Forward-Deployed Regulatory Affairs/Medical Writer to join our team. The role is embedded with pharma/biotech partners, evaluating AI-generated regulatory content and guiding submissions.

You will collaborate with client regulatory and medical writing teams, ensure quality and compliance for CTD/NDA submissions, and help refine AI-driven regulatory workflows across IND through commercial phases.

Qualifications

• 5+ years of Regulatory Affairs or Medical Writing in pharma/biotech.
• Bachelor's degree required; advanced degree preferred (Ph.D., Pharm.D., M.D., or M.S.).
• Strong understanding of regulatory requirements and ICH/FDA/EMA expectations.
• Experience authoring regulatory documents across CTD modules and submissions (IND through NDA/BLA/MAA).
• Familiarity with eCTD structure and end-to-end submission process.

Responsibilities

• Evaluate and improve AI agent performance on regulatory writing tasks for IND/NDA docs.
• Partner with client regulatory/medical writing teams to ensure QA for submissions.
• Build benchmarks and acceptance criteria for regulatory writing workflows.
• Collaborate with regulatory professionals to deploy AI in document preparation workflows.
• Act as regulatory content authority on AI outputs for accuracy and compliance.
• Work with Forward Deployed Engineers and Go-to-Market on engagements.

Skills

Regulatory Affairs

Medical Writing

Regulatory submissions

Education

Bachelor's degree

Ph.D./Pharm.D./M.D./M.S. in life sciences

Tools

Veeva Vault

Documentum

eCTD knowledge

Job description

Edison Scientific, Inc. is seeking a Forward-Deployed Regulatory Affairs/Medical Writer to join our team. The role is embedded with pharma/biotech partners, evaluating AI-generated regulatory content and guiding submissions.

You will collaborate with client regulatory and medical writing teams, ensure quality and compliance for CTD/NDA submissions, and help refine AI-driven regulatory workflows across IND through commercial phases.