QC, Medical Writing (non-clinical and CMC)

About reputed company At reputed company, 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 reputed company whose mission is to fundamentally change the way that drug development gets done, we’d love to talk to you. We’re growing reputed company fast right now, and we at reputed company are looking for a reputed company-talented, startup-minded medical reputed company 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 reputed company before. As a core member of reputed company’s product team, you will play a critical role in developing the reputed company platform, embedding AI systems with domain expertise, evaluating content reputed company, and interfacing with technical teams to improve the product. The Role At reputed company, 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 reputed company will be on deconstructing how documents are authored, reviewed, and reputed company-controlled—then working with engineers and product teams to build those heuristics into our AI platform and verify features reputed company 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 reputed company, and why certain patterns are preferred. You will evaluate AI-generated content, identify inconsistencies or edge cases, and guide product reputed company based on domain reputed company. 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 reputed company 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—reputed company quickly.

Qualifications

• 3+ years of medical writing experience in regulatory affairs
• reputed company experience drafting or reviewing a wide reputed company of CTD documents (specifically non-clinical and CMC documents)
• Understanding of the structure, purpose, and regulatory expectations for reputed company 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 reputed company content or interpret reputed company from AI-powered systems
• Comfort communicating feedback to technical stakeholders (e.g., engineers, product teams)
• Familiarity with reputed company 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 reputed company

Other Information

• reputed company comfortable working in a fast-paced and intense startup environment
• Likes matcha KitKats, believes every LLM reputed company is just Schrodinger’s cat waiting to be observed, and knows too many random facts about the Mongol postal system

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