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Principal Medical Writing Product Lead

Faro Health - California, CA, United States - In-office - posted 2026-08-13

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Faro Health is building an AI-enabled platform to transform how clinical trial documents are authored. The company helps life sciences teams turn study design into high-quality clinical and regulatory documents efficiently. This is a hybrid product and domain expertise role—not a traditional medical writing position. You will serve as the medical writing expert embedded in product development, helping define how AI should generate, review, and maintain clinical trial protocols and related regulatory documents from structured study data. Your responsibilities include: • Design the medical writing product workflow, translating real authoring pain points and regulatory requirements into clear product decisions alongside Product and Engineering teams. • Define quality standards for AI-generated content, establishing practical criteria for scientific accuracy, consistency, traceability, narrative quality, and appropriate expert judgment. • Own the evaluation framework for medical writing quality, including representative datasets, metrics, acceptance criteria, failure mode analysis, and comparison with expert-authored documents. • Help determine how structured study data should transform into regulatory-grade narrative and how content should adapt when underlying study design changes. • Partner directly with selected customers during pilot deployments, learning their workflows, identifying high-value opportunities, and supporting adoption of new human-in-the-loop processes. • Bring medical writing credibility to customer conversations, confidently discussing how AI improves authoring without compromising quality or trust. • Challenge the status quo—identify work that can be simplified, automated, or removed entirely while preserving essential scientific and regulatory judgment. You'll work closely with Product, Engineering, Customer Strategy, clinical experts, and strategic customers. The role emphasizes learning quickly from real-world deployments and scaling successful approaches into core product capabilities. Required: 7+ years of medical writing in pharma, biotech, or CRO environments with substantial responsibility for complex clinical and regulatory documents. Deep experience authoring clinical trial protocols and amendments is essential; experience with clinical study reports, investigator brochures, or submission content is strongly preferred. You must understand clinical development workflows, cross-functional inputs (Medical, Clinical Operations, Biostatistics, Regulatory, Safety, Data Management), global regulatory expectations, and document standards. Demonstrated ability to lead document review across multiple contributors, resolve inconsistencies, and translate complex scientific decisions into clear writing is required.

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