U
Member of Technical Staff- Regulatory Affairs/Medical Writer
Unknown
34d ago
0$180k - $250kWritingRemote, USjobspy_indeed
remoteindeed
Job Description
**Location**
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Remote available (U.S. Only)
**Employment Type**
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Full time
**Location Type**
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Remote
**Department**
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ResearchScience Research
**Compensation**
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* $180K – $250K • Offers Equity
**About us**
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Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. We are an ambitious team run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.
**Role**
We are looking for a **Forward\-Deployed Regulatory Affairs/Medical Writer** to join our Forward Deployed team. In this role, you will be working onsite with pharma and biotech partners alongside our engineers. You'll evaluate agent drafted content, build benchmarks to measure quality, and work with our partners' regulatory and medical writing teams to find where AI can meaningfully accelerate document preparation across the submission lifecycle. You bring the regulatory judgment that determines whether AI generated text is submission ready or needs rework.
This is embedded, partner facing work. You'll build credibility with regulatory and clinical teams, understand their writing conventions and agency expectations, and feed insights back to our AI team to improve how our platform reasons about regulatory content, structure, and scientific argumentation.
This position will ideally sit in San Francisco, Boston, or NYC; Remote is an option along with the ability to travel 20\-40% of the time.
**Responsibilities**
* 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.
**Requirements**
* 5\+ years of experience in Regulatory Affairs or Medical Writing within the pharmaceutical or biotechnology industry, ideally within a sponsor organization
* Bachelor's degree required; advanced degree preferred (Ph.D., Pharm.D., M.D., or M.S. in a life sciences discipline)
* Strong understanding of regulatory requirements and familiarity with ICH guidelines a
