Senior Principal Medical Writer

General Description

This position is responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and lifecycle management of products in Bei Gene pipeline. The clinical and regulatory documents include, but are not limited to, clinical study protocols, investigator brochures, clinical study reports, regulatory briefing documents, clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions, and other types of clinical and regulatory documents within the working scope of global medical writing.

This position is also responsible for mentoring MWs (full-time employees and/or contractors/vendors) as needed.

Manages assigned writing tasks, ensures documents adhere to relevant regulatory guidelines and Bei Gene SOP/WI(s), templates, and style guide. Manages multiple documents simultaneously, including complex documents (e.g., those with complex content, urgent timeline, or external collaboration). Proactively leads direction and strategy setting, critically analyzes, synthesizes, and presents complex information for document development in collaboration with study team(s). Guides other MWs. Leads creation and maintenance of document writing template/guidance for all document types within scope.

Navigates uncertainties to develop and manage timelines for individual documents and multiple documents supported by different MWs in one project (e.g., works as the MW filing lead for an NDA/BLA/MAA submission). Guides other MWs. Proactively identifies questions/issues/potential risks requiring departmental or team discussion, creates mitigation plans, and resolves problems efficiently. Builds strong and in-depth relationships with study team(s) and program team(s) (e.g., works as the MW program lead).

Understands the role of own documents within the larger dossier and voices impacts on upstream and downstream processes.

Proactively identifies needs for process/tool optimization and establishment. Leads departmental process/tool optimization, departmental process/tool establishment, cross-functional process/tool optimization, cross-company process/tool optimization.

Leads development of new training programs. Provides instructions and training (content-wise/process-wise) to other MWs. Provides systematic technical and operational mentorship to MWs (full-time employees and/or contractors/vendors).

Understands global MW scope and guides study team(s) and program team(s) within defined scope and responsibility following established processes. Provides topic sharing on regulatory writing and related knowledge within the department and across functional stakeholders and across companies (e.g., DIA and medical writing communities).

None.

An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred. BS with a minimum of 7 years of regulatory document writing (or equivalent) experience, Masters with 5+ or PhD/PharmD/MD with a minimum of 3+ years of regulatory document writing (or equivalent) experience.

Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.

On occasion, as needed.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

$ - $ annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.

All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan.

The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any…