北京招聘

职位描述：
SUMMARY OF DUTIES AND RESPONSIBILITIES
主要职责

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
豪洛捷是一家领先同侪，集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、外科手术产品于一体的公司，以服务全球妇女医疗健康需求为己任。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球妇女得以享受更健康、更长寿的生活。目前hologic亟需优秀人才的加入。


Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信，人才是公司宝贵的财富，只有通过招聘、培训、发展、保留最优秀的人才，我们才能持续成功。

Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
我们的工作氛围是促进创新和以客户为中心。我们为员工提供先进的工具和技术，合作和充满激情的工作环境，以提升世界各地的医疗保健水平。

We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
公司总部位于马萨诸塞州，在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
我们正在迅速成长，我们将更加关于于人民、成长与未来。这是一个激动人心的历史时刻，可以访问我们的网站以了解更多的职业生涯的机会。

Hologic has commercial organization, R&D, MFG facilities in China. China Headquarter is in Beijing. We aim to build China Organization an exciting place to work and grow professionally.
豪洛捷在中国设置了完整的商业机构，包括研发、生产等。总部位于北京，我们致力于打造积极的、专业的商业运营机构。

1. Take charge of the management and operation of clinical trial projects, coordinate cross-functional team(s) in the execution of clinical trials
全面负责临床试验项目的管理和运作，协调临床试验项目实施过程中不同职能团队的日常工作
2. Operate integrally with product core team to align clinical timelines and budget
与产品核心团队共同确定临床试验时间表以及预算
3. Set and manage goals and timelines for projects encompassed by the product strategy; building and maintaining project timelines and interdependencies
设定及管理符合产品策略的临床试验目标和项目时间表，建立和维护项目时间表并确保实施
4. Proactively communicate status of clinical trial deliverables to clinical management, core team, and other stakeholders including executive management
及时与临床管理、核心团队以及其它相关人员/部门，包括高级管理层就临床试验进展情况进行沟通和汇报
5. Facilitate appropriate interim and final reviews of study data in preparation of regulatory submissions
协助完成注册申报文件提交时所需的研究数据的中期及最后审查
6. Design and maintain study budget and performance metrics
设计和维护研究预算及绩效衡量标准
7. Manage clinical affairs through plans (mitigate clinical trial risk)
通过计划对临床事务进行管理（减少临床试验风险）
8. Execute, negotiate and maintain supply agreements with suppliers
配合供应商协商、实施及维持供应协议
9. Manage and facilitate resolution of clinical trial risks or issues; plan and implement contingencies as appropriate.
管理临床试验风险或问题并协助解决；就意外情况的解决进行适当的规划和实施
10. Meet with cross-functional Clinical Affairs team members to prepare team meetings, capture meeting minutes and assign key action items with single points of accountability
约见跨职能临床事务团队成员，准备团队会议、收集会议纪要并分配关键待办事项以确保实施
11. Interact with RA/QA in responding to audits and FDA/ CFDA inquiries
与注册部门合作对审计以及FDA/ CFDA的相关质询做出回应


QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Abundant professional experiences of clinical trial as well as good understanding of related laws and regulations
丰富的临床试验专业经验以及对相关法律法规的深入理解
2. Demonstrated excellence in leadership. teamwork and communication skills including relationship building skills with team members, peers, and senior leaders
出色的领导能力、团队合作能力以及沟通技巧，包括与团队成员、同事及高级别管理人员建立良好合作关系的能力
3. Broad and thorough understanding of clinical trial process including: study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation and project finance accounting
深入、彻底理解临床试验流程，包括：研究的设计和实施、临床数据管理系统、临床试验管理系统、数据分析以及数据报告和解释、项目财务核算等
4. Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
能够同时管理多个项目及相互冲突的优先事项，具备随时调整优先事项的灵活性
5. Hard-working, clear thinking logic, result-oriented, willing to travel
工作勤奋，清晰的逻辑思维能力，结果导向，适应出差
6. Fluent English both in writing and speaking
流利的口头和书面英文能力



EDUCATION

1. Degree in health-related discipline
医学相关专业学士及以上




EXPERIENCE

1. BS with 8+ years of experience, or MS with 6+ years of experience, or PhD with 3+ years of experience
学士学历8年以上工作经验、硕士学历6年以上工作经验或博士学历3年以上工作经验
2. 8+ years of experience in clinical project/program management, clinical trial practices and regulations
8年以上临床项目管理、临床试验以及相关法规相关的实际经验
3. Experience leading cross-functional teams and projects
管理跨职能团队及项目的经验
4. Experience in Imaging products (preferred), medical device, or pharmaceutical industry
影像产品（优先）、医疗器械或药品行业工作经验 举报 分享

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
豪洛捷是一家领先同侪，集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、外科手术产品于一体的公司，以服务全球***医疗健康需求为己任。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球***得以享受更健康、更长寿的生活。目前hologic亟需优秀人才的加入。

Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信，人才是公司宝贵的财富，只有通过招聘、培训、发展、保留***的人才，我们才能持续成功。

Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
我们的工作氛围是促进创新和以客户为中心。我们为员工提供***的工具和技术，合作和充满激情的工作环境，以提升世界各地的医疗保健水平。

We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
公司总部位于马萨诸塞州，在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
我们正在迅速成长，我们将更加关于于人民、成长与未来。这是一个激动人心的历史时刻，可以访问我们的网站以了解更多的职业生涯的机会。

Hologic has commercial organization, R&D, MFG facilities in China. China Headquarter is in Beijing. We aim to build China Organization an exciting place to work and grow professionally.
豪洛捷在中国设置了完整的商业机构，包括研发、生产等。总部位于北京，我们致力于打造积极的、专业的商业运营机构。