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.

Job Description:

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 clinical 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.

百济神州全球胜任力

当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越

• 团队协作
• 提供并征求坦诚及可行的反馈
• 自我认知
• 兼容并蓄
• 积极主动
• 开拓精神
• 持续学习
• 拥抱变化
• 结果导向
• 分析性思维/数据分析
• 卓越财务
• 清晰沟通

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

求职者隐私申明：

百济神州致力于尊重和保护求职者的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理求职者的个人信息（包括个人敏感信息，如有）。更多详情，敬请查阅百济神州《求职者隐私政策》。

BeOne is committed to respect and protect job applicants’ personal information rights, and will process job applicants’ personal information, including sensitive personal information if any, based on the principles of legality, legitimacy, necessity, and integrity. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

由于百济神州在全球范围内开展业务，我们需要基于集团人力资源统筹管理的合理业务目的而向百济神州关联公司（BeOne Medicines Ltd.）提供求职者的简历及求职信息，求职者的信息将被存储在位于中国境外（目前位于美国）的Workday数据库。如需行使中国法律规定的各项个人信息权利，可通过[email protected]联系BeOne Medicines Ltd.

Due to the reasonable business need for human resource management as a result of BeOne’s global operation, job applicants’ resume and job application relevant information may be provided to the BeOne affiliate (BeOne Medicines Ltd.), and the aforementioned data will be stored in Workday (currently located in the U.S.). If the job applicant wishes to exercise his/ her personal information rights provided under PRC laws, he/ she may contact BeOne Medicines Ltd. via [email protected].

如您主动向我们提供您的个人信息，则视为您已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则（尤其是向中国境外提供个人信息）。如您主动向我们提供其他求职者的个人信息，则视为您确认相关人员已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则（尤其是向中国境外提供个人信息）。

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms (especially the cross-border transfer of job applicants’ personal information). 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 BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms (especially the cross-border transfer of job applicants’ personal information).

如您对此有任何疑问的，请勿提交任何简历信息或其他个人信息。

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