Senior Principal Medical Writer
Not Disclosed•Full-TimeOn-site
location_onBen Franklin Court, San Mateo, San Mateo County, California, 94401, United States
About the Role
This position serves as a strategic partner in the development of high-quality, fit-for-purpose clinical and regulatory documents. The role is critical to facilitating the speed of information throughout the development, submission, approval, and life-cycle management of products within the BeiGene pipeline.
You will manage the creation of complex documents, including clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules for INDs, NDAs, BLAs, and MAAs. Beyond individual authorship, this role acts as a mentor to medical writers, guiding both full-time employees and contractors/vendors in best practices and regulatory compliance.
Day in the Life
As a leader in medical writing, you will navigate uncertainties to develop and manage timelines for individual documents and complex multi-document projects, such as serving as the filing lead for major submissions. You will proactively identify risks, questions, and issues, developing mitigation plans and resolving problems efficiently.
A significant portion of your time will be dedicated to establishing and optimizing processes and tools. You will lead departmental initiatives to improve document writing templates and guidance, while also contributing to cross-functional and cross-company process improvements. You will build strong relationships with study and program teams, ensuring your documents align with the larger dossier strategy and providing insights on upstream and downstream impacts.
You will also drive knowledge sharing by developing training programs, providing systematic technical and operational mentorship, and presenting on regulatory writing topics to internal stakeholders and external communities, such as the DIA.
Equal Opportunity
BeiGene is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work location
Work model: On-site
Ben Franklin Court, San Mateo, San Mateo County, California, 94401, United States
San Mateo, California
Key Responsibilities
Similar Job Opportunities
Skills, education and keywords
Skills: Microsoft Word, Adobe Acrobat, Electronic Document Management Systems, Microsoft Outlook, Excel, Powerpoint.
Education: Advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred..
Frequently asked questions about Senior Principal Medical Writer at BeOne Medicines
What does a Senior Principal Medical Writer at BeOne Medicines do?expand_more
In this Senior Principal Medical Writer at BeOne Medicines role, you will lead document development strategy by analyzing, synthesizing, and presenting complex information; share regulatory writing knowledge and expertise with cross-functional stakeholders and external communities; develop and manage timelines for individual and multiple complex regulatory documents; and lead departmental process and tool optimization and establishment initiatives.
What are the requirements for this Senior Principal Medical Writer role?expand_more
BeOne Medicines is looking for candidates who meet the following requirements: Advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science preferred; BS with minimum 7 years regulatory document writing experience; Masters with 5+ years regulatory document writing experience; PhD/PharmD/MD with minimum 3+ years regulatory document writing experience; Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; and Proficiency in Microsoft Outlook, Excel, and PowerPoint.