QC, Medical Writing (non-clinical and CMC)
About Artos At Artos, we build tools that help biopharma companies create and manage their R&D documentation in a fraction of the time. If you’re looking to join a team whose mission is to fundamentally change the way that drug development gets done, we’d love to talk to you. We’re growing very fast right now, and we at Artos are looking for a hyper-talented, startup-minded medical writer who can help us accelerate the development of a product that supports companies from innovative biotech startups to some of the largest pharmaceutical companies in the world in their mission to deliver life-saving treatments to patients faster than ever before. As a core member of Artos’s product team, you will play a critical role in developing the Artos platform, embedding AI systems with domain expertise, evaluating content quality, and interfacing with technical teams to improve the product. The Role At Artos, you will not be in a traditional medical writing position. We are on a mission to change the way that documentation is created and managed in drug development companies. You will primarily be responsible for helping design the systems that write documents that these companies produce, particularly in the non-clinical and/or CMC domains. While deep regulatory writing knowledge is essential, your primary focus will be on deconstructing how documents are authored, reviewed, and quality-controlled—then working with engineers and product teams to build those heuristics into our AI platform and verify features ahead of release. Your objective is to help the system generalize the principles behind medical writing and ensure the system follows those principles: which content goes where, how it should be structured, and why certain patterns are preferred. You will evaluate AI-generated content, identify inconsistencies or edge cases, and guide product decisions based on domain insight. You’ll work across the full landscape of R&D documentation—not just the Common Technical Document (CTD), but also supporting content like internal summaries, briefing packages, templates, and sponsor-facing outputs. We don’t expect you to know how to write all of these documents, but we do expect that you will learn how to do so—and how to communicate those learnings to a deeply technical engineering audience—very quickly.
Qualifications
- 3+ years of medical writing experience in regulatory affairs
- Direct experience drafting or reviewing a wide range of CTD documents (specifically non-clinical and CMC documents)
- Understanding of the structure, purpose, and regulatory expectations for each major CTD document type
- Experience reviewing documents for compliance with FDA, EMA, and ICH guidelines
- Strong writing, editing, and documentation skills
- Strong QC capabilities
- Experience working cross-functionally with regulatory teams and subject matter experts
Requirements
- Ability to analyze new document types and quickly learn relevant structures and content expectations
- Ability to extract and document rules, patterns, and logic used in regulatory writing
- Ability to review structured content or interpret output from AI-powered systems
- Comfort communicating feedback to technical stakeholders (e.g., engineers, product teams)
- Familiarity with structured content formats such as XML or JSON is preferred
- Experience working in or with life sciences software tools is a plus
- Ability to work independently and manage multiple writing and review tasks in parallel
Other Information
- Very comfortable working in a fast-paced and intense startup environment
- Likes matcha KitKats, believes every LLM prompt is just Schrodinger’s cat waiting to be observed, and knows too many random facts about the Mongol postal system
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