Job Description

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 life-cycle management of products in BeiGene pipeline. The c linical and regulatory documents include, but are not limited to, clinical study protocol, investigator brochures, clinical study reports, clinical modules of IND submissions, and clinical modules for NDAs, BLAs, MAAs and other regulatory submissions (eg, clinical summaries and bridging study evaluation report)

Essential Functions of the Job:

Document Writing

• Manages the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as BeiGene SOP/WI(s), template(s), and style guide.
• Be able to manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration). Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s).
• Contributes to the creation and maintenance of document writing template/guidance for the document types listed in the General Description part.

Project /Program Management

• Navigates through uncertainties to develop and manage timeline of individual documents.
• Be able to identify the questions/issues that require departmental discussion or team discussion with guidance from line manager/mentor. Be able to identify the potential risks and make a mitigation plan with guidance from line manager/mentor. Resolves problems with guidance from line manager/mentor (eg, takes concrete actions according to the aligned decisions).
• Builds relationship with study team(s).
• Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes.

Process/Tool Establishment and Optimization

• Proactively identifies needs for process/tool optimization and establishment, and proposes solutions.
• Contributes to departmental process/tool optimization and establishment.

Training and Mentoring

• Contributes to the development of new training programs.
• Helps junior MWs with the planning and execution for document development as requested.

Influence

• Understands the global MW scope and works to guide study team(s) within the defined scope and responsibility following established processes.
• Provides topic sharing on global MW deliverables and related knowledge within the department.

Qualification Required:

Education Required:

An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science is preferred.

MS with a minimum of 3 years of regulatory document writing (or equivalent) experience.

PhD/PharmD/MD with regulatory document writing (or equivalent) experience is preferred.

Other Qualifications:

• Effective Communication Confidently presents the issues related to own work to others. Be able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from line manager/mentor. Takes part in discussions with different viewpoints, and be able to provide value added‑ inputs.
• Embracing Change Always seeking and open to new opportunities and changes. Willing to explore new and different solutions when faced with new challenges. Copes well with change and new challenges, recognizing the benefits for self and the department. Contributes to specific change activities.
• Creating Innovation Demonstrates the willingness to change perspectives and ideas that are no longer relevant and learn new skills or techniques. Proposes innovative ideas and suggests new approaches to tackle own work tasks and issues in a better way.
• Thinking Strategically Understands how concepts (eg, strategic review, lean writing) relate to own work, and applies principles (eg, best practices for strategic review, lean writing) when appropriate. Understands company strategies and general events happening in the industry (eg, regulations, guidelines, and trends), and knows how current and emerging trends affect own role.
• Mentoring Provides constructive, behaviorally-oriented feedback to others within the team as requested. Willingly shares own knowledge and experience to support others’ learning.

Computer Skills:

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

Travel:

On occasion, as needed

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.