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Regulatory Medical Writer II

CBSET, Inc. • Lexington, MA, US • published 2026-11-05 06:59:20.725317

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Description

About CBSET CBSET is a preclinical translational contract research organization (CRO) with a 20\-year legacy of supporting medical device and biopharma sponsors through rigorous, science\-driven safety and efficacy testing, complex histopathology, specialized toxicology, and both lab\-based and consulting services. Backed by Arlington Capital Partners, CBSET is scaling its commercial engine as part of a multi\-year aggressive growth plan. This is supported by organic business growth, and a new state\-of\-the\-art facility build that substantially increases the capacity of current capabilities and enables new service lines for the business. Position Summary The Regulatory Medical Writer I is an entry\-level professional responsible for drafting, editing, and formatting early\-stage regulatory submission documents for both pharmaceutical drugs (INDs) and medical devices (510k applications). Operating under direct supervision, this role focuses on translating complex scientific, preclinical data into clear, compliant, and submission\-ready documentation. The Regulatory Medical Writer I works closely with cross\-functional teams—including Regulatory Affairs, Sponsors, and Operations—to...


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