临床供应链专员
Clinical Supply Chain Specialist
BeOne持续以快速的节奏增长，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，我们寻找高度积极、善于合作，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。
职位概述：
· 在直接经理或团队负责人监督下，临床供应链专家负责与临床试验相关的药物供应活动，包括计划、标签开发、标签与包装以及分发。在经理或团队负责人的指导下，积极制定并监督供应计划，确保患者获得准确且连续的供应，同时降低风险并减少浪费。在指导之下，可能参与团队以制定和实施流程改进，为组织未来发展奠定基础。
岗位核心职责：
- 与团队负责人或经理协作，了解临床需求要求，并确保与研究团队的供应计划和时间表保持一致。
- 与内部（如临床运营、法规、质量、CMC）和外部利益相关者（如CMO、IRT供应商）进行协作和沟通。
- 在指导下，制定供应策略，以最大化供应效率，减少浪费，同时识别风险并制定风险缓解计划。
- 与团队负责人或经理协作，制定供应和库存计划，并为临床试验材料制定生产计划。
- 监控生产计划的时间表执行情况，必要时进行调整。
- 与标签管理团队协作，确保标签文本和样稿符合相关规则、法规、产品规格和临床研究方案。
- 协助比较剂采购团队执行已制定的比较剂采购策略/活动。
- 支持IRT用户验收测试，制定IRT供应策略（DNX参数），并监督系统中的持续供应活动。
- 协调并跟踪发往CMO、仓库和供应商的批量运输。维护并跟踪进口许可证。
- 参与执行IRT系统的UAT验收测试
- 支持与IRT相关的活动，确保临床试验的充足供应
- 其他所需职责
管理职责：
· 无
计算机技能：
· 熟练使用Microsoft Word、Excel和Outlook
其他资格要求：
- 良好的分析、沟通和人际交往能力。
- 良好的组织能力。
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.
General Description:
· Under the supervision of the direct manager or team lead, the Specialist of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for clinical trials. With the guidance of the manager or team lead, actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. With guidance, may participates on teams to develop and implement process improvements to build the organization for the future.
Essential Functions of the Job:
- Work with team lead or manager to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
- Collaborate and liaise with internal (e.g. Clinical Operations, Regulatory, Quality, CMC) and external stakeholders (e.g. CMOs, IRT vendors) appropriately.
- With guidance, outline supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
- Work with team lead or manager to create supply and inventory plans and develop production schedules for clinical trial materials.
- Monitor schedule adherence of production schedules and make course corrections if needed.
- Work with label management team to ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
- Assist with comparator sourcing team to conduct developed comparator sourcing strategies/activities.
- Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
- Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.
- Participate in performing UAT acceptance testing for IRT systems
- Supports IRT related activities to ensure adequate supply for clinical trials
- Additional responsibilities as required
Supervisory Responsibilities:
· N/A
Computer Skills:
· Proficient in Microsoft Word, Excel, and Outlook
Other Qualifications:
- Good analytical, communication and interpersonal skills.
- Good organizational and effective time management skills.
- Good problem-solving and risk management skills.
- Good at Microsoft Office Tools
Education Required:
- Bachelor’s degree or above in Medicine/science related, or supply chain/management/operation related, or equivalent combination of education, training and experience.
- 2+ years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
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: $79,100.00 - $109,100.00 annuallyBeOne 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