Senior Principal Medical Writer
Not Disclosed•Full-TimeOn-site
location_onHeritage Square, 5915;6121, Hollis Street, Emeryville, Alameda County, California, 94608, United States
About the Role
This position serves as a strategic partner in the development of high-quality clinical and regulatory documents, ensuring the efficient flow of information throughout the product lifecycle at BeiGene. From initial development through submission, approval, and life-cycle management, you will support the BeiGene pipeline by crafting essential documents such as clinical study protocols, investigator brochures, clinical study reports, and regulatory briefing documents for INDs, NDAs, BLAs, and MAAs.
Beyond individual contribution, this role acts as a mentor and guide for other medical writers, including full-time employees and contractors. You will navigate complex project landscapes, setting direction and strategy for document development while fostering strong relationships with study and program teams. Your work ensures that documents not only adhere to regulatory guidelines and internal standards but also fit seamlessly into the larger regulatory dossier, minimizing upstream and downstream impacts.
Team Context & Mission
As a key member of the global medical writing function, you will help establish and optimize the processes and tools that drive our regulatory success. You will lead initiatives to create and maintain writing templates and guidance, while proactively identifying opportunities for cross-functional and cross-company process improvements. Your expertise will be shared internally and externally, contributing to the broader medical writing community through knowledge sharing at industry forums such as DIA meetings.
Hiring Process
Candidates selected for this role will engage in a structured interview process designed to assess technical expertise, strategic thinking, and cultural fit. This typically includes a review of writing samples, followed by interviews with the hiring team and cross-functional stakeholders to evaluate collaboration skills and leadership potential.
Equal Opportunity Employer
BeiGene is committed to building a diverse and inclusive workforce. 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
Heritage Square, 5915;6121, Hollis Street, Emeryville, Alameda County, California, 94608, United States
Emeryville, California
Key Responsibilities
- check_circleLead the creation and maintenance of document writing templates and guidance for all document types
- check_circleShare regulatory writing knowledge and expertise with cross-functional stakeholders and external communities
- check_circleLead departmental process and tool optimization and establishment initiatives
- check_circleDevelop training programs and provide systematic technical mentorship to medical writers
- check_circleManage clinical and regulatory document writing tasks to ensure adherence to guidelines and company standards
- check_circleIdentify potential risks and develop mitigation plans for document development projects
- check_circleDevelop and manage timelines for complex documents and multiple submissions including NDA, BLA, and MAA
- check_circleBuild strong relationships with study teams and program teams to ensure document alignment
Requirements
- verifiedAdvanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science preferred
- verifiedBS with minimum 7 years regulatory document writing experience
- verifiedMasters with 5+ years regulatory document writing experience
- verifiedPhD/PharmD/MD with minimum 3+ years regulatory document writing experience
- verifiedTechnical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems
- verifiedProficiency in Microsoft Outlook, Excel, and PowerPoint
Nice to Have
An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science.
Similar Job Opportunities
Skills, education and keywords
Skills: Microsoft Word, Adobe Acrobat, Electronic Document Management Systems, Microsoft Outlook, Excel, Powerpoint.
Education: Master's in life science, pharmacy, medical, or health-related science preferred; PhD in life science, pharmacy, medical, or health-related science 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 the creation and maintenance of document writing templates and guidance for all document types; share regulatory writing knowledge and expertise with cross-functional stakeholders and external communities; lead departmental process and tool optimization and establishment initiatives; and develop training programs and provide systematic technical mentorship to medical writers.
What are the requirements for this Senior Principal Medical Writer role?expand_more
To qualify for the Senior Principal Medical Writer at BeOne Medicines position, applicants should have: 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.
Where is the Senior Principal Medical Writer role at BeOne Medicines located?expand_more
Senior Principal Medical Writer at BeOne Medicines is based in Heritage Square, 5915;6121, Hollis Street, Emeryville, Alameda County, California, 94608, United States. This is a on-site role.
Is this Senior Principal Medical Writer job remote, hybrid, or on-site?expand_more
BeOne Medicines has listed this Senior Principal Medical Writer role as on-site.
How much experience is required for this Senior Principal Medical Writer role?expand_more
Senior Principal Medical Writer at BeOne Medicines typically requires 3+ years of relevant experience at the senior level.
What skills do you need for the Senior Principal Medical Writer role at BeOne Medicines?expand_more
Key skills for Senior Principal Medical Writer at BeOne Medicines include Microsoft Word; Adobe Acrobat; Electronic Document Management Systems; Microsoft Outlook; Excel; and Powerpoint.
What education is required for Senior Principal Medical Writer at BeOne Medicines?expand_more
Educational requirements for this role: Master's in life science, pharmacy, medical, or health-related science preferred; and PhD in life science, pharmacy, medical, or health-related science preferred.
What category does the Senior Principal Medical Writer role belong to?expand_more
Senior Principal Medical Writer at BeOne Medicines is part of the scientific & qa job category on Recrutus.