Senior Medical Writing Lead – Regulatory Documents

structuretx; South San Francisco (CA); Hybrid; USD 186,000 - 235,000; Full time

Benefits offered by this job

Annual bonus

Equity

401k match

Health insurance

Unlimited PTO

Job summary

Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory and clinical document development, ensure regulatory compliance, and manage multiple projects in a fast-paced environment.

You will provide strategic guidance on writing templates, perform QC reviews, collaborate with Clinical Sciences, Regulatory Affairs, Biostatistics, and Program Management, and mentor other writers.

Qualifications

• BA, BS or advanced degree in life sciences, pharmacy, or related field.
• 5+ years of regulatory medical writing experience.
• Knowledge of global regulatory requirements (FDA, EMA, ICH).
• Experience authoring regulatory/clinical documents and QC reviews.
• Excellent written and verbal communication, attention to detail.

Responsibilities

• Lead authoring/review/finalization of regulatory and clinical documents (CSRs, Protocols, IBs, Briefing Documents, CTD Module 2).
• Ensure compliance with regulatory requirements and internal standards.
• Provide strategic guidance on writing templates and processes.

Skills

Regulatory writing

Project management

Attention to detail

Written communication

Regulatory operations

Team leadership

Education

PhD/PharmD/MS

Tools

Veeva

EndNote

Microsoft Word

Adobe Acrobat

Smartsheet

Job description

Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory and clinical document development, ensure regulatory compliance, and manage multiple projects in a fast-paced environment.

You will provide strategic guidance on writing templates, perform QC reviews, collaborate with Clinical Sciences, Regulatory Affairs, Biostatistics, and Program Management, and mentor other writers.