Member of Technical Staff- Regulatory Affairs/Medical Writer

About Us

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.

About the Role

We are looking for a 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.

Key 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.

Required Qualifications

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 and FDA/EMA expectations

Hands on experience authoring regulatory documents such as CTD module sections, clinical study reports, investigator brochures, and briefing documents, with exposure across IND through commercial submissions (NDA, BLA, MAA)

Familiarity with eCTD structure and the end to end submission process from authoring through publishing

Experience in therapeutic areas such as oncology, immuno-oncology, immunology, cardiovascular, neurology, or hepatology (MASH) preferred

Experience with regulatory information management systems such as Veeva Vault or Documentum

Ability to travel 20-40% of the time

Preferred Qualifications

Familiarity with AI assisted writing or document automation tools

High comfort with ambiguity and fast iteration

Salary

$180,000 - $250,000 • Offers equity

Why join us?

We're a fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it. We also offer full-time employees the following:

Competitive salary and equity

Full healthcare coverage; we pay 100% of premiums for you and your dependents

Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot

Mental health support through Rula, our in-network therapist and psychiatrist network with fast availability

12 weeks of paid parental leave for maternity, paternity, and adoption

Pet care support with a yearly employer-funded stipend for your animal companions

Commuter benefits so you can pay for transit and parking with pre-tax dollars

401(k) company matching

$300 health and wellness benefit quarterly

Lunch is on us every day you're in the office, and dinner is on us when you're working late

Regular team off-sites and company events

Edison Scientific is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.