• Interpret complex clinical study protocols and other medical/scientific documentation • Prepare and coordinate laboratory specification and study-specific medical/technical documents • Partner with internal departments in document development, drafting, review, editing, and finalization • Manage multiple rounds of internal and external document review • Serve as a subject-matter expert (SME) for medical documentation • Participate in client interactions during study start-up activities • Maintain knowledge of FDA, MHRA, NYSDOH regulations • Resolve challenges and build consensus among cross-functional groups and collaborators