Associate Director, Medical Writing (SF Bay Area)

Role: Associate Director of Medical Writing leading regulatory and clinical document development for a clinical-stage biopharma focused on cardiovascular, metabolic, and pulmonary diseases. Responsibilities: authoring and reviewing high-quality documents (e.g., protocols, study reports, IBs), ensuring compliance with FDA, EMA, ICH standards; conducting QC reviews; managing multiple projects across cross-functional teams (Clinical, Regulatory, Biostatistics, CMC); providing strategic guidance on documentation practices; tracking quality metrics; and supporting regulatory submissions. Requirements: BA/BS or advanced degree (PhD, PharmD, MS) in life sciences; 5+ years in regulatory medical writing within pharma/biotech; deep knowledge of global regulatory guidelines; extensive experience with regulatory and clinical documents; strong editing, communication, and project management skills; proficiency in Word, Adobe, Veeva, and related tools. Preferred qualifications include experience in biotech or biologics, familiarity with global regulatory processes, and ability to coordinate across multiple time zones. High-value specifics: clinical-stage pipeline, emphasis on regulatory document standards, quality control, and collaboration with cross-disciplinary teams. Work setup: not specified, but given the global scope, remote or hybrid work likely; no travel explicitly mentioned.