Associate Director, Medical Writing - Bay Area

Role: Associate Director of Medical Writing leading the development of regulatory and clinical documents for Structure Therapeutics' drug pipeline, primarily supporting cardiovascular, metabolic, and pulmonary indications. Responsibilities: authoring, reviewing, and finalizing documents such as Study Protocols, Study Reports, Investigator Brochures, and regulatory responses; ensuring compliance with FDA, EMA, ICH standards; conducting QC reviews for accuracy, formatting, and data integrity; managing multiple projects and cross-functional collaboration with Clinical Sciences, Regulatory Affairs, Biostatistics, and others; providing strategic guidance on document standards and best practices. Requirements: BA/BS or advanced degree in life sciences or pharmacy; 5+ years of regulatory medical writing experience within pharma or biotech; strong knowledge of global regulatory guidelines; proven ability to produce and QC high-quality regulatory documents; excellent communication, organizational, and project management skills; proficiency with document management tools such as Veeva, Microsoft Word, and Adobe Acrobat. Preferred: experience supporting biologics, small molecules, or gene therapies, and familiarity with drug development stages from preclinical to post-market. The role involves remote work with mandatory monthly attendance in SSF, CA, and may include some travel. The position offers a competitive base salary ($186,000–$235,000) plus incentives, equity, and comprehensive benefits.