Associate Director, Clinical Data Management
Structure Therapeutics
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. #LIHybrid
POSITION SUMMARY
The Associate Director of Regulatory Medical Writing will play a key role in ensuring the accuracy, consistency, and quality of regulatory and clinical documents across our drug development programs. This role will focus on performing quality control (QC) reviews, document formatting, and editing to ensure that all documents meet regulatory standards, internal guidelines, and best practices. The ideal candidate will have a strong background in regulatory medical writing, exceptional attention to detail, and experience in QC processes for regulatory documentation. This role will report to the Director, Medical Writing and will be an individual contributor. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Quality Control & Editing
- Perform thorough quality control reviews of regulatory and clinical documents including Clinical Study Reports, Clinical Study Protocols, Investigator Brochures, Module 2 summaries (CTD sections), Briefing Documents, and other submission materials to ensure accuracy, consistency, and compliance with regulatory guidelines (e.g., FDA, EMA, ICH).
- Ensure all documents are grammatically correct, internally consistent, match source data, and are free of errors in spelling, punctuations, formatting, and data presentation.
- Document Formatting & Compliance:
- Format documents according to company templates, style guides, and regulatory requirement, ensuring consistency across all submissions.
- Ensure proper use of tables, figures, references, cross-references, and verify that all data and citations are accurate and appropriately presented.
- Maintain version control of documents and manage document workflows to ensure timely completion and submission.
- Process Improvement:
- Identify opportunities to improve document quality, efficiency, and consistency across the medical writing function.
- Provide training and guidance to internal team members on best practices for document formatting, editing, and quality control.
- Provide feedback and support to medical writers to enhance the quality of their work and ensure adherence to established guidelines and templates.
- Track and report on quality metrics related to document preparation, editing, and QC activities, identifying trends and areas for improvement.
REQUIREMENTS
Education
- Degree (B.S., or equivalent) in life sciences, pharmacy, or a related field. Advanced degree (M.S. or equivalent preferred).
Experience
- A minimum of 8 years of experience in regulatory medical writing within the pharmaceutical or biotechnology industry, with at least 3 years in a quality control, editing, or formatting-focused role.
- Extensive experience in quality control review and editing of regulatory documents, with a strong understanding of regulatory requirements and the drug development process.
- Exceptional attention to detail and accuracy, with a proven ability to identify and correct inconsistencies, errors, and formatting issues.
- Strong proficiency with Microsoft Word, Adobe Acrobat, EndNote, and other software used for document preparation and editing.
Licenses or Certifications
Travel - 20%
The target salary range for this full-time role is $182,000 - $219,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.