Associate Director, Medical Writing - Bay Area

Posted today

scorpion therapeuticsSouth San Francisco (CA)

Regulatory Affairs Specialists Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

SALARY

$186,000 per year

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About the role

RoleAssociate Director of Medical Writing leading the development of regulatory and clinical documents for Structure Therapeutics' drug pipeline, primarily supporting cardiovascular, metabolic, and pulmonary indications. Responsibilitiesauthoring, 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. Preferredexperience supporting biologics, small molecules, or gene therapies, and familiarity with drug development stages from preclinical to post-market. Location & TravelThe role involves remote work with mandatory monthly attendance in SSF, CA, and may include some travel.

Compensation & Benefits: The position offers a competitive base salary ($186,000–$235,000) plus incentives, equity, and comprehensive benefits.

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