Associate Director Medical Writing — South San

About Us

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. Our 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. 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 operates at the center of life science innovation in both the US and China, capitalizing on the unique strengths of each geographic location.

About the Role

As the Associate Director of Medical Writing, you will lead the development of key regulatory and clinical documents supporting the company’s drug development programs. This role is designed for a seasoned medical writing professional who thrives in a fast-paced environment and possesses the ability to manage multiple complex projects simultaneously.

You will serve as a key liaison between Medical Writing and cross-functional stakeholders, ensuring alignment on content, strategy, and messaging. Your day-to-day will involve conducting comprehensive quality control reviews to ensure documents are accurate, internally consistent, and compliant with regulatory standards. You will provide strategic guidance on regulatory writing best practices and foster a culture of continuous improvement by supporting other medical writers.

Hiring Process & Application

Direct candidates should apply through our official career page at BambooHR. We require that all recruitment vendors have a fully executed, formal written agreement on file; unsolicited resumes from agencies will be considered without contract.

Remote Work Requirement: If hired as a remote employee, you are required to attend Connection Week one week every month in San Francisco, CA.

Fraud Alert: Recruiters will always contact you using the domain of Structuretx.com. We will never request payments or sensitive financial information. If you are unsure if a message is from Structure Therapeutics, please email human resources.

Equal Opportunity & Culture

Structure Therapeutics Inc. is an Equal-Opportunity Employer. We are committed to fair and equitable compensation practices and strive to provide employees with total compensation packages that are market competitive. We consider qualified applicants regardless of background.

Work location

Work model: Hybrid

206, B Street, Baden, South San Francisco, San Mateo County, California, 94080, United States

South San Francisco, California

Key Responsibilities

check_circleLead authoring, review, and finalization of regulatory and clinical documents
check_circleConduct comprehensive quality control reviews for accuracy and compliance
check_circleEnsure documents adhere to FDA, EMA, and ICH regulatory requirements
check_circleManage medical writing deliverables across multiple projects with on-time completion
check_circleCollaborate with cross-functional teams to gather and integrate required content
check_circleProvide strategic guidance on regulatory writing best practices and templates
check_circleTrack and analyze quality metrics to drive continuous improvement
check_circleServe as a key liaison between Medical Writing and cross-functional stakeholders

Requirements

verifiedBA, BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, pharmacy, or related field
verified5+ years of experience in regulatory medical writing within pharmaceutical or biotech industry
verifiedIn-depth knowledge of global regulatory requirements, guidelines, and drug development process
verifiedHigh proficiency with Microsoft Word, Adobe Acrobat, EndNote, Veeva, Smartsheet, and related systems

Benefits & Perks

check_circleMedical, dental, and vision insurancecheck_circle401k matchcheck_circleUnlimited PTOcheck_circleAnnual performance incentive bonusNew hire equity

Skills, education and keywords

Skills: Microsoft Word, Adobe Acrobat, Endnote, Veeva, Smartsheet, Regulatory Medical Writing, Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, CTD Module 2.

Education: PhD in life sciences, pharmacy, or related field.

Frequently asked questions about Associate Director, Medical Writing at Structure Therapeutics

What does a Associate Director, Medical Writing at Structure Therapeutics do?expand_more

Day-to-day, the Associate Director, Medical Writing at Structure Therapeutics will lead authoring, review, and finalization of regulatory and clinical documents; conduct comprehensive quality control reviews for accuracy and compliance; ensure documents adhere to fda, ema, and ich regulatory requirements; and manage medical writing deliverables across multiple projects with on-time completion.

What are the requirements for this Associate Director, Medical Writing role?expand_more

To qualify for the Associate Director, Medical Writing at Structure Therapeutics position, applicants should have: BA, BS or advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, pharmacy, or related field; 5+ years of experience in regulatory medical writing within pharmaceutical or biotech industry; In-depth knowledge of global regulatory requirements, guidelines, and drug development process; and High proficiency with Microsoft Word, Adobe Acrobat, EndNote, Veeva, Smartsheet, and related systems.

Where is the Associate Director, Medical Writing role at Structure Therapeutics located?expand_more

Associate Director, Medical Writing at Structure Therapeutics is based in 206, B Street, Baden, South San Francisco, San Mateo County, California, 94080, United States. This is a hybrid role.

Is this Associate Director, Medical Writing job remote, hybrid, or on-site?expand_more

Structure Therapeutics has listed this Associate Director, Medical Writing role as hybrid.

How much experience is required for this Associate Director, Medical Writing role?expand_more

Associate Director, Medical Writing at Structure Therapeutics typically requires 5+ years of relevant experience at the lead level.

What skills do you need for the Associate Director, Medical Writing role at Structure Therapeutics?expand_more

Key skills for Associate Director, Medical Writing at Structure Therapeutics include Microsoft Word; Adobe Acrobat; Endnote; Veeva; Smartsheet; Regulatory Medical Writing; Clinical Study Protocols; and Clinical Study Reports.

What education is required for Associate Director, Medical Writing at Structure Therapeutics?expand_more

Educational requirements for this role: PhD in life sciences, pharmacy, or related field.

What category does the Associate Director, Medical Writing role belong to?expand_more

Associate Director, Medical Writing at Structure Therapeutics is part of the scientific & qa job category on Recrutus.

Associate Director, Medical Writing