Structure Therapeutics
Associate Director, Regulatory Medical Writing
Structure Therapeutics, South San Francisco, California, us, 94083
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
Reporting to Director, Medical Writing, the Associate Director of Regulatory Medical Writing will be an individual contributor and will be responsible for leading the preparation of key regulatory documents that support the company's clinical development programs. This role requires a seasoned medical writing professional with a strong understanding of regulatory requirements, clinical studies, and the ability to manage multiple projects in a fast-paced environment. The ideal candidate will have experience in regulatory medical writing, a passion for clinical science, and the ability to collaborate effectively with cross-functional teams. This is a hybrid role that will require 3 days in the office (2 core days and 1 flex day).
REQUIREMENTS
Regulatory Document Preparation:
Lead the development, review, and finalization of high-quality regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, Briefing Documents, Module 2 Summaries (CTD sections), and responses to regulatory agency requests.Ensure that all documents are prepared in compliance with regulatory guidelines (e.g., FDA, EMA, ICH), company standards, and timelines.Provide guidance on regulatory writing best practices, templates, and processes to ensure accuracy and consistency in messaging across documents.
Collaboration & Communication:
Act as a key liaison between the medical writing team and cross-functional stakeholders, ensuring alignment on messaging and content.Participate in cross-functional meetings and contribute to strategic planning for documents.
Project Management:
Manage the medical writing aspects of multiple regulatory and clinical documents, ensuring timelines and quality standards are met.Coordinate with cross-functional teams, including Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Preclinical Development, CMC, and Program Management to gather the necessary information for document preparation.Monitor project progress, anticipate potential issues, and proactively implement solutions to ensure successful project completion.
REQUIREMENTS
EducationAdvanced degree (Ph.D., Pharm. D, M.S., or equivalent) in life sciences, pharmacy, or a related field.
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 leadership or managerial role.Strong knowledge of regulatory requirements and guidelines and the drug development process.Proven experience in preparing regulatory and clinical documents.Excellent written and verbal communication skills, with the ability to convey complex scientific and clinical data clearly and effectively.Strong project management skills and the ability to lead cross-functional teams.Demonstrated ability to manage multiple projects simultaneously and work effectively in a fast-paced, dynamic environment.Ability to work across global time zones and with global teams.
Travel - 20%
The target salary range for this full-time role is $191,000 - $230,000 + 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.
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
Reporting to Director, Medical Writing, the Associate Director of Regulatory Medical Writing will be an individual contributor and will be responsible for leading the preparation of key regulatory documents that support the company's clinical development programs. This role requires a seasoned medical writing professional with a strong understanding of regulatory requirements, clinical studies, and the ability to manage multiple projects in a fast-paced environment. The ideal candidate will have experience in regulatory medical writing, a passion for clinical science, and the ability to collaborate effectively with cross-functional teams. This is a hybrid role that will require 3 days in the office (2 core days and 1 flex day).
REQUIREMENTS
Regulatory Document Preparation:
Lead the development, review, and finalization of high-quality regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, Briefing Documents, Module 2 Summaries (CTD sections), and responses to regulatory agency requests.Ensure that all documents are prepared in compliance with regulatory guidelines (e.g., FDA, EMA, ICH), company standards, and timelines.Provide guidance on regulatory writing best practices, templates, and processes to ensure accuracy and consistency in messaging across documents.
Collaboration & Communication:
Act as a key liaison between the medical writing team and cross-functional stakeholders, ensuring alignment on messaging and content.Participate in cross-functional meetings and contribute to strategic planning for documents.
Project Management:
Manage the medical writing aspects of multiple regulatory and clinical documents, ensuring timelines and quality standards are met.Coordinate with cross-functional teams, including Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Preclinical Development, CMC, and Program Management to gather the necessary information for document preparation.Monitor project progress, anticipate potential issues, and proactively implement solutions to ensure successful project completion.
REQUIREMENTS
EducationAdvanced degree (Ph.D., Pharm. D, M.S., or equivalent) in life sciences, pharmacy, or a related field.
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 leadership or managerial role.Strong knowledge of regulatory requirements and guidelines and the drug development process.Proven experience in preparing regulatory and clinical documents.Excellent written and verbal communication skills, with the ability to convey complex scientific and clinical data clearly and effectively.Strong project management skills and the ability to lead cross-functional teams.Demonstrated ability to manage multiple projects simultaneously and work effectively in a fast-paced, dynamic environment.Ability to work across global time zones and with global teams.
Travel - 20%
The target salary range for this full-time role is $191,000 - $230,000 + 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.