Senior Medical Writer

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 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 J ob: 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 Power P oint , 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 Me