Associate Director, Medical Writing - Bay Area

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.

• 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.

• 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.

• 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.