Remote Associate Director, Medical Writing — Regulatory Strategy

Structure Therapeutics; South San Francisco (CA); Hybrid; 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

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