structuretx

structuretx

Associate Director, Medical Writing

South San Francisco, California · Director

Sponsorship not specified$186k-$235kDetected 20 days ago
Project ManagementStakeholder ManagementFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationOrganizational SkillsMicrosoft OfficeBiostatisticsRegulatory Affairs

About the role

  • Verify the accuracy and presentation of tables, figures, references, cross-references, and source data.
  • Serve as a key liaison between Medical Writing and cross-functional stakeholders to ensure alignment on content, strategy, and messaging.

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.
  • Track, analyze, and report quality metrics related to document development and QC activities, identifying trends and driving continuous improvement.
  • Proactively monitor project progress, identify risks, and implement mitigation strategies to support successful outcomes.

Requirements

  • BA, BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, pharmacy, or a related field.
  • In-depth knowledge of global regulatory requirements, guidelines, and the drug development process.
  • Excellent written and verbal communication skills, with the ability to clearly and effectively convey complex scientific and clinical information.
  • Exceptional attention to detail, with a proven ability to identify and correct inconsistencies, errors, and formatting issues.
  • 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.
  • Collaborate with cross-functional teams (Clinical Sciences, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Nonclinical, CMC, and Program Management) to gather and integrate required content.
  • 5+ years of experience in regulatory medical writing within the pharmaceutical or biotech industry.
  • Demonstrated experience authoring and contributing to a wide range of regulatory and clinical documents.
  • Extensive experience conducting quality control (QC) reviews and editing regulatory documents for accuracy, consistency, and compliance.
  • 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.
  • Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Compensation

  • Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.

Benefits

  • Manage medical writing deliverables across multiple projects, ensuring high quality documents with on-time completion.

Company info

  • 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 completed an initial public offering (IPO) in February 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.
  • 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.
  • 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 completed an initial public offering (IPO) in February 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.
  • 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.
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