远程工作雷达

医学写作研究员

Medical Writing Fellow

市场运营限定地区(需当地身份)
公司BeiGene
薪资$75,000/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

BeOne持续以快速的速度增长,为有经验的专业人士提供具有挑战性和令人兴奋的机会。在考虑候选人时,我们寻找具有高度积极性、协作精神,并且最重要的是,对抗击癌症充满热情的科学和商业专业人士。
2027年7月前获得生命科学、药学、医学或与健康相关的科学领域的高级学位(硕士/博士/药学博士/医学博士)。
该为期1年的职位负责提供专业知识,以支持开发高质量、符合用途的临床和监管文件,以加快BeOne管线中产品在开发、提交、审批及生命周期管理过程中的信息传递速度,在直线经理/导师的支持下进行。临床和监管文件包括但不限于临床研究方案、研究者手册、临床研究报告以及IND提交的临床模块。
**申请时,请上传简历(CV)、意向信和非正式的大学成绩单**
岗位核心职责:

文档撰写:

  • 管理分配的撰写任务,确保文件符合相关法规指南,以及BeOne的SOP/WI、模板和风格指南。
  • 能够在复杂文件(例如内容复杂、时间紧迫或涉及外部合作)的开发过程中,与跨职能团队协作管理多份文件。与研究团队协作,参与文件开发的方向和策略制定(包括批判性分析、综合和呈现复杂信息)。
  • 根据自身经验,就可用的文档撰写模板/指导提供反馈。

项目/计划管理:

  • 制定并管理单个文件的时间表。管理时间表的不确定性和变更。
  • 能够识别需要部门或团队讨论的问题/议题,能够识别潜在风险,并提出问题的解决方案。
  • 与研究团队建立联系。

流程/工具建立与优化:

  • 识别流程/工具优化和建立的需求。
  • 就与自身工作相关的部门流程/工具提供反馈。

培训与辅导:

  • 参与并就现有培训项目提供反馈。

影响力:

  • 理解全球MW范围,并努力推动相关工作。
查看英文原文

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.
An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science by July 2027.
This 1-year 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 BeOne pipeline with support from line manager/mentor.. The clinical and regulatory documents include, but are not limited to, clinical study protocol,investigator brochures, clinical study reports, and clinical modules of IND submissions
**When applying, please upload curriculum vitae (CV), letter of intent, and your unofficial college transcript**
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 BeOne SOP/WI(s), template(s), and style guide.
  • Be able to manage multiple documents at the development of complex documents (eg, those with complex content, urgent timeline, or external collaboration) in collaboration with cross-functional teams. Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s).
  • Provides feedback regarding available document writing template/guidance for the document types with experience.

Project/Program Management:

  • Develops and manages timelines of individual documents. Manages uncertainties and changes to timelines.
  • Be able to identify the questions/issues that require departmental discussion or team discussion . Be able to identify the potential risks . Proposes resolutions for problems.
  • Builds connection with study team(s).

Process/Tool Establishment and Optimization:

  • Identifies needs for process/tool optimization and establishment.
  • Provides feedback regarding available departmental process/tool related to own work.

Training and Mentoring:

  • Participates in and provides feedback regarding available training programs.

Influence:

  • Understands the global MW scope and works to guide study team(s) within the defined scope and responsibility following established processes.
  • Provides insight on global MW deliverables and related knowledge within the department.
  • Other Qualifications:
  • Effective Communication: Explains own work clearly. Be able to escalate questions/issues to appropriate stakeholders at an early stage. 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. Copes well with change and new challenges. Provides feedback regarding specific change activities.
  • Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work. Provides feedback regarding the innovative ideas and new approaches and uses them to tackle own work tasks and issues in a better way.
  • Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work. Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).
  • Mentoring: Provides specific feedback to others within own team as requested.

Computer Skills:
Technical expertise in Microsoft Word, Adobe Acrobat; proficiency in Microsoft Outlook, Excel, and PowerPoint, etc.
Travel:
On occasion, as needed.
Pay Rate: 75K/Year
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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

Salary Range: $ - $ per hourBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. 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 to 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 other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
Originally posted on Himalayas

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