Principal Medical Writer

About the Role

This position serves as a strategic partner in the development of high-quality, fit-for-purpose clinical and regulatory documents. The primary mission is to facilitate 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 critical documents, including clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, and clinical modules for INDs, NDAs, BLAs, and MAAs. Beyond individual writing tasks, this role involves leading direction and strategy for complex document development, synthesizing intricate information, and collaborating closely with study teams.

A key component of this position is mentorship. You will guide junior Medical Writers (both full-time employees and contractors/vendors), providing technical and operational instruction to help them navigate uncertainties and adhere to regulatory guidelines and BeiGene SOPs.

Team Context & Impact

In this role, you will act as a bridge between the document and the broader dossier, understanding how your work impacts upstream and downstream processes. You will build strong relationships with study and program teams, identifying potential risks and developing mitigation plans to ensure successful submissions.

You will also contribute to the optimization of departmental processes and tools, proactively proposing solutions to improve efficiency. Your expertise will extend beyond the immediate team through topic sharing on regulatory writing within the department and across the industry, such as at DIA meetings and medical writing communities.

Application & Interview Process

Submit your application with your resume and relevant writing samples.
Initial Screening: A brief conversation with the recruiting team to discuss your background and interest in the role.
Technical Assessment: A review of your writing capabilities and regulatory knowledge.
Team Interview: A discussion with the hiring manager and potential team members to assess cultural fit and collaboration style.
Final Review: Offer discussion and onboarding preparation.

Equal Opportunity Employer

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

check_circleIdentify needs for process and tool optimization and propose solutions
check_circleProvide topic sharing on regulatory writing to departmental and cross-functional stakeholders
check_circleLead strategy and direction for complex document development in collaboration with study teams
check_circleDevelop and manage timelines for individual documents and multiple document submissions
check_circleLead the development of training programs and provide technical mentorship to junior medical writers
check_circleManage clinical and regulatory document writing tasks to ensure adherence to guidelines and company standards
check_circleIdentify potential risks, create mitigation plans, and resolve project issues
check_circleCreate and maintain document writing templates and guidance for specific document types
check_circle

Requirements

verifiedAdvanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science
verifiedBachelor's with 5+ years regulatory document writing experience
verifiedMS with 4+ years regulatory document writing experience
verifiedPhD/PharmD/MD with 2+ 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.

Skills, education and keywords

Skills: Microsoft Word, Adobe Acrobat, Electronic Document Management Systems, Microsoft Outlook, Excel, Powerpoint.

Education: Bachelor's in life science, pharmacy, medical, or health-related science with 5+ years experience; PhD in life science, pharmacy, medical, or health-related science with 2+ years experience.

Frequently asked questions about Principal Medical Writer at BeOne Medicines

What does a Principal Medical Writer at BeOne Medicines do?expand_more

A Principal Medical Writer at BeOne Medicines is responsible for the following: Identify needs for process and tool optimization and propose solutions; Provide topic sharing on regulatory writing to departmental and cross-functional stakeholders; Lead strategy and direction for complex document development in collaboration with study teams; and Develop and manage timelines for individual documents and multiple document submissions.

What are the requirements for this 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; Bachelor's with 5+ years regulatory document writing experience; MS with 4+ years regulatory document writing experience; PhD/PharmD/MD with 2+ 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 Principal Medical Writer role at BeOne Medicines located?expand_more

Principal Medical Writer at BeOne Medicines is based in Ben Franklin Court, San Mateo, San Mateo County, California, 94401, United States. This is a on-site role.

Is this Principal Medical Writer job remote, hybrid, or on-site?expand_more

BeOne Medicines has listed this Principal Medical Writer role as on-site.

How much experience is required for this Principal Medical Writer role?expand_more

Principal Medical Writer at BeOne Medicines typically requires 2+ years of relevant experience at the lead level.

What skills do you need for the Principal Medical Writer role at BeOne Medicines?expand_more

Key skills for 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 Principal Medical Writer at BeOne Medicines?expand_more

Educational requirements for this role: Bachelor's in life science, pharmacy, medical, or health-related science with 5+ years experience; and PhD in life science, pharmacy, medical, or health-related science with 2+ years experience.

What category does the Principal Medical Writer role belong to?expand_more

Principal Medical Writer at BeOne Medicines is part of the scientific & qa job category on Recrutus.