Associate Director, Medical Writing - Bay Area

Structure Therapeutics; South San Francisco (CA); On-site; USD 186,000 - 235,000; Full time

Job summary

Structure Therapeutics seeks an Associate Director of Medical Writing to lead development of regulatory and clinical documents for its drug pipeline, supporting cardiovascular, metabolic, and pulmonary indications. This role partners with Clinical Sciences, Regulatory Affairs, Biostatistics, and others to ensure high-quality submissions.

The position emphasizes compliance with FDA/EMA/ICH standards, document management best practices, and cross-functional leadership, with a remote-first setup

Qualifications

• 5+ years of regulatory medical writing experience in pharma or biotech.
• BA/BS or higher in life sciences or pharmacy.
• Strong knowledge of global regulatory guidelines.
• Proven ability to produce and QC high-quality regulatory documents.
• Excellent communication, organizational, and project management skills.

Responsibilities

• Authoring, reviewing, and finalizing Study Protocols, Study Reports, Investigator Brochures, and regulatory responses.
• Ensuring compliance with FDA, EMA, ICH standards.
• QC reviews for accuracy, formatting, and data integrity.
• Managing multiple projects with cross-functional collaboration.
• Providing strategic guidance on document standards and best practices.

Skills

Regulatory medical writing

Project management

Communication

Organizational skills

Attention to detail

Education

BA/BS or advanced degree in life sciences or pharmacy

Tools

Veeva

Microsoft Word

Adobe Acrobat

Job description

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.

Location & Travel

The 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.