Position Summary:
The Associate Director of Medical Writing will be responsible for leading the development of key regulatory and clinical documents supporting the company's drug development programs, while also performing quality control (QC) reviews, document formatting, and editing to ensure compliance with regulatory standards, internal guidelines, and best practices. This role requires a seasoned medical writing professional with the ability to manage multiple projects in a fast-paced environment. The ideal candidate will have deep experience in regulatory medical writing and regulatory operations, exceptional attention to detail, and the ability to collaborate effectively with cross-functional teams.
Job Responsibilities:
Regulatory & Clinical Document Development:
- Lead the authoring, review, and finalization of high-quality regulatory and clinical documents, including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, Briefing Documents, CTD Module 2 summaries, and responses to regulatory agency information requests.
- Ensure all documents comply with applicable regulatory requirements (FDA, EMA, ICH), internal standards, and timelines.
- Provide strategic guidance on regulatory writing best practices, templates, and processes to ensure clarity, consistency, and alignment of messaging across documents.
Quality Control & Document Standards:
- Conduct comprehensive QC reviews to ensure documents are accurate, internally consistent, data-driven, and compliant with regulatory and company standards.
- Ensure documents are properly formatted according to approved templates, style guides, and submission requirements.
- Verify the accuracy and presentation of tables, figures, references, cross-references, and source data.
- Track, analyze, and report quality metrics related to document development and QC activities, identifying trends and driving continuous improvement.
Project & Stakeholder Management:
- Manage medical writing deliverables across multiple projects, ensuring high quality documents with on-time completion.
- Collaborate with cross-functional teams (Clinical Sciences, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Nonclinical, CMC, and Program Management) to gather and integrate required content.
- Proactively monitor project progress, identify risks, and implement mitigation strategies to support successful outcomes.
Collaboration & Leadership:
- Serve as a key liaison between Medical Writing and cross-functional stakeholders to ensure alignment on content, strategy, and messaging.
- Contribute to cross-functional meetings and strategic planning related to regulatory and clinical documents.
- Provide feedback and support to other medical writers, promoting adherence to standards and continuous enhancement of writing quality.
Education & Qualifications:
- BA, BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, pharmacy, or a related field.
- 5+ years of experience in regulatory medical writing within the pharmaceutical or biotech industry.
- In-depth knowledge of global regulatory requirements, guidelines, and the drug development process.
- Demonstrated experience authoring and contributing to a wide range of regulatory and clinical documents.
- Excellent written and verbal communication skills, with the ability to clearly and effectively convey complex scientific and clinical information.
- Extensive experience conducting quality control (QC) reviews and editing regulatory documents for accuracy, consistency, and compliance.
- Exceptional attention to detail, with a proven ability to identify and correct inconsistencies, errors, and formatting issues.
- Strong project management and organizational skills, including the ability to lead and collaborate with cross-functional teams.
- Proven ability to manage multiple projects simultaneously and thrive in a fast-paced, dynamic environment.
- Experience working with global teams across multiple time zones.
- High proficiency with document management and authoring tools, including Microsoft Word, Adobe Acrobat, EndNote, Veeva, Smartsheet, and related systems.
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $186,000 - $235,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience. If you are hired as a remote employee, a requirement is to attend Connection Week one week every month in SSF, CA.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
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