Forward-Deployed Regulatory Affairs Medical Writer - Remote

Edison Scientific, Inc.; United States; Ibrido; USD 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Healthcare coverage

Parental leave

Mental health support

401(k) matching

Wellness stipend

Team off-sites

Transit benefits

Descrizione del lavoro

Edison Scientific is seeking a Forward-Deployed Regulatory Affairs/Medical Writer to work onsite with pharma and biotech partners, evaluating AI-generated regulatory content, refining submissions, and guiding IND through NDA module drafting with scientific and regulatory judgment.

You will partner with regulatory and medical writing teams, build benchmarks, set acceptance criteria, and deploy AI into document preparation workflows while traveling 20–40% to client sites; remote options may be

Competenze

• 5+ years experience in regulatory affairs or medical writing in pharma/biotech.
• Bachelor’s degree; advanced degree preferred (PhD/MD/PharmD/MS in life sciences).
• Experience with CTD module writing and eCTD submission process.
• Familiarity with ICH guidelines and FDA/EMA expectations.

Mansioni

• Evaluate and improve AI agent performance on regulatory and medical writing tasks including IND and NDA module drafting, clinical study reports, investigator brochures, briefing documents, and response to agency queries.
• Partner with end users at client organizations to validate that our AI generated regulatory documents meet the quality, accuracy, and compliance bar required for health authority submissions.
• Build benchmarks and acceptance criteria for regulatory writing focused agent workflows.
• Work directly with regulatory affairs professionals and medical writers at partner organizations to deploy AI agents into their document preparation workflows.
• Act as the regulatory content authority on AI generated outputs, assessing scientific accuracy, guideline compliance, internal consistency, and narrative quality.
• Collaborate daily with Forward Deployed Engineers on each account and support engagement scoping, success metrics, and technical evaluation with the Go-to-Market team.

Conoscenze

Regulatory Affairs

Medical Writing

FDA/EMA familiarity

Formazione

Bachelor’s degree

Advanced degree (PhD/PharmD/MD/MS)

Strumenti

Veeva Vault

Documentum

Descrizione del lavoro

Edison Scientific is seeking a Forward-Deployed Regulatory Affairs/Medical Writer to work onsite with pharma and biotech partners, evaluating AI-generated regulatory content, refining submissions, and guiding IND through NDA module drafting with scientific and regulatory judgment.

You will partner with regulatory and medical writing teams, build benchmarks, set acceptance criteria, and deploy AI into document preparation workflows while traveling 20–40% to client sites; remote options may be