雇主关注问题：
未来3-5年计划
Build up BJ office is a very import step for our whole china strategy. i think from RA side .
Let me try and give you an analogy: the process of product registration like brought up a child. At first, we might have no time and energy do brought up a child by our self. so we need the nanny [ˈnæni] to take care of them. but if we have time, it's much better for us to take care of the baby by our selves.
RA role
1. pre-market registration activities, such as make registration strategy according to commercial requirements, new products registration, adding indication. CRO Clinical trial supervision
2. Post marked roles: participate in NMPA audit, deal with complains and CAPA with other functional group.
3. Key Internal and external customer communication(make strong and positive relationship): Internal such as R&D, PMO, Sales and marketing, and finace. External include NMPA, Testing center, CRO and industrial association.
1. T-SOPT Renew. 2. NMPA Audit 3. New product. 4 Adding indication. 5. Agency transfer.
希望和公司一起成长，当然更重要的是着眼当下，做好当下的工作。
对于Oxford的认识，产品经验
Oxford Immunotec is a global, high-growth diagnostics company focused on developing and commercializing proprietary assays for immunology and infectious disease. The Company’s T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA
2002 funded in UK, T-SPOT CE-Mark 2004, FDA PMA 2008, China approval 2010 2014 SH office
T-SPOT CMV and PRT CE-Mark 2015
2个注册证，1个一类，1个二类
工作独立性和主动性，新项目量，多任务处理能力（工作节奏），
区分重要紧急事项，合理规划，
项目中有无主动提出建议，如有如何实时跟进总结
如何确保时间节点
general timeline，speed up to save some buffer。weekly or daily review。
家庭情况，
家人都很支持我的工作。和老人在一起，老婆做homebase 工作。
比较大的挑战，
离职原因，Personal development
薪资较低，发展受限
出差
喜欢的领导风格。
虽然有更适合的领导风格，但是更主要的是自己的适应能力。
问公司的问题
1. 您对这个职位的期许 what is your expectation for this position?’
2. 未来公司发展计划
3. 部门未来的发展计划
4. 是否新产品
4.
1. 做哪个产品线？免疫?生化？具体？每年新产品多少？每个人手中大概多少张注册证？ 2. 晋升机会有多大？ 3. 临床怎么做？ 4. 福利待遇问人力 特殊问题：
1. 能盛 Morning Katie, cindy and Leila. My name is Xinsheng Wang, you can call me Shawn. it is relly a great honor to have opportunity for this interview. i hope i can make a good performance today, now let me introduce myself breaf. After grated from Peking University majoring biosicese in 2010, i have worked about 6 years regulatory registration experience including 1 year in MD and 5 year IVD. i have completed about 100 projects such as new ,renew changing administrative changing IFU filing Class i filing. so i'm condidence do to this job very well. Please trust me, you won't be let down. Thank you very much for interviewing me today. My reading and writing English is excellent, but my job in the past years didn't require spoken English skills that much, my spoken English is just so so. But if the new job need it, i believe I can grasp it well. I am totally confident that I can do this job very well. I will try my best to take the responsibility and do everything as good as I can. Please trust my loyalty and effort, you won't be let down.Thank you very much for interviewing me today. 作者：林燕凤 链接：https://www.jianshu.com/p/a65b1ac8c41f 來源：简书 简书著作权归作者所有，任何形式的转载都请联系作者获得授权并注明出处。 作者：林燕凤 链接：https://www.jianshu.com/p/a65b1ac8c41f 來源：简书 简书著作权归作者所有，任何形式的转载都请联系作者获得授权并注明出处。 a. 为什么考虑我们公司？ 发展 personal developing. challenge and opportunity 可以接触各种产品，各种情况，一家公司产品很有局限性。 甲方和乙方区别就。内容可能区别不大。但工作 是要有服务意识Teamwork and customer service spirit;，与客户的沟通更加重要。 LBE可能要求更严格，你的一举一动都代表公司而不代表部门。责任更重。 说话办事更要有理有据。 1. 你能在两分钟内自我推荐吗？对你目前的工作，能否做个概括的说明 2. Why did you leave your last job？(你为什么离职呢？) 寻求更好的职业发展，尤其像罗氏这么优秀的公司，我更是想抓住。 3.你还有什么问题要问吗？ 你个性上最大的特点是什么？耐心和细心 “请谈谈你对我们公司的认识/看法。” 你对目前/从前的工作单位有何贡献？ sorry, I didn't follow you, can you please repeat it Thank you for your interview. 1．How many clinical studies have you been responsible for managing in your career? I have completed nearly 100 projects from many companies. including MD,IVD.Renew, change and new. 2. How many testing have you conducted? I have conducted over 30, including tt, panel verification and industrial standard verification. 3. This position may require some travel. What percentage of time are you able to travel? It would be better the travel is less than 50% except urgent matter. 4. Have you conducted or monitored any clinical studies under the more robust CFDA quality requirements? I went through changes of CFDA regulations over these years. The regulations have been modifying and requiring more details. I always adjust my work in order to fit regulations. a. If Yes, what were the outcomes of the site audits? I have one project which was audited by CFDA , the result is that CFDA think serum must come from different patient, but my product is used to monitor microbial infection and cure status. 5. In your experiences working at CROs, please share an example of a challenging situation with a customer. What was your role in resolving the situation? What was the outcome? 3 lots of products are needed for TT, but their is only 2 months left for us to shipping, customer clearance for an urgent projects. First, we keep close touch with logistics for customer documents preparation. It only takes us 2 weeks for shipping and customer even though the product includes human materials which usually takes 1 month . Secondly, when we got the product there is only one month left for TT. You know the test engineer have a lot of projects, so they could not do it within month but we communicate which them early to set aside time for this testing meantime we communicate which the officer for green road. CMDE End of Feb submit, 正常一般要12个月，leader ask us to get the license within this year it is to say 10 month 2 month shorter then us. Service life data, 9 submit the supplemental document, we’l’ll got the license within this year. The requirement Customer required us to complete the clinical trials within one year. But CFDA old regulations required that clinical trials must be started after completing type testing under the supervision of the CFDA. However, customer failed several times, so we got less time. On the one hand, I increased my CRA in this project. On the other hand, I communicated with the hospital to do a lot of work ahead of schedule. At last we completed the project on time. 6. As NAMSA IVD is a growing, global business we work together in a very collaborative way and often do work outside of the typical job description to help the team. Would you be comfortable speaking to potential clients about our IVD clinical/regulatory expertise, speaking on a webinar (in the Chinese language would be acceptable) or attending conferences on behalf of NAMSA to support our growth expectations? I think it is correct method. In my opinion, it is necessary that we communicate with the potential client in advance to get more accurate project information. And I can offer some professional knowledge to business colleagues, making potential clients think NAMSA is more professional than other companies. 7. Throughout your career in the CRO IVD industry, what has been your involvement in preparing proposals and cost estimates for clinical studies? During the period of DDM, communicating with site about the cost of clinical trials and making quotation to potential were my duty. 8. Which aspects of conducting clinical trials would you consider to be strengths? First of all, the ability to learn is very important, because CFDA regulations have been changing and CRO have been receiving advanced techniques products. And I understand requirements of CFDA regulations and GCP .In addition make scientific and reasonable plan and implement it effectively. In the end, Effective communication both with research and with CRA. 9. If you were to join the NAMSA IVD team, what support would you like to have from me or the NAMSA team in China to support your career growth and development? I can learn how NASMA manage medical devices clinical trials, I want to improve my oral English. 10. What excites you about joining the NAMSA IVD team? I know NAMSA will conduct clinical trials in Europe and the United States in addition to clinical trials in China. I can learn how other countries conduct clinical trials. 11. What questions can I help to answer about the NAMSA IVD team? Can I participate in the clinical trial of this international multi-center trials?
英语面试常见问题
Q： Can you sell yourself in two minutes？ Go for it.（你能在两分钟内自我推荐吗？大胆试试吧！）
A： Ok, it is really a great honor to be here for this interview, i'm Shawn. With my qualifications and experience, I feel I am the right person you're looking for. Firstly, i have 6 years of RA experience , 1 year for medical device and 5 year for IVD. so I have a lot of value experience in registration. Secondly, i have been in 2 world famous company J&J, ABBOTT, so this experience is also helpful for me to be in oxford. Finally, I have a strong background in bioscience knowledge, especially in immunology, so it will take a short time for me to get familiar with our product. All in all, i believe i can qualify the job very well.
Q：Give me a summary of your current job description. (对你目前的工作，能否做个概括的说明。)
A：I have been in Abbott working as a RA role for over 3 years . To be specific, I do product TT, labeling review. (我干了五年的电脑程序员。具体地说，我做系统分析，解决问题以及软件供应方面的支持。）
Q：Why did you leave your last job？(你为什么离职呢？)
A： Well, I am hoping to get an offer of a better position. If opportunity knocks, I will take it.（我希望能获得一份更好的工作，如果机会来临，我会抓住。）
A：I feel I have reached the "glass ceiling" in my current job. / I feel there is no opportunity for advancement. （我觉得目前的工作，已经达到顶峰，即没有升迁机会。)
Q：How do you rate yourself as a professional？(你如何评估自己是位专业人员呢？)
A： With my teaching experience, I am capable and competent. (凭借我良好的学术背景，我可以胜任自己的工作，而且我认为自己很有竞争力。）
Q： What contribution did you make to your current (previous) organization？(你对目前/从前的工作单位有何贡献？)
A： I have finished 4 new projects, and all of them are ahead of our committed LBE. (我已经完成三个新项目，我相信我能将我的经验用在这份工作上。)
Q：What do you think you are worth to us？(你怎么认为你对我们有价值呢？)
A：I feel I can make some positive contributions to your company in the future. (我觉得我对贵公司能做些积极性的贡献。)
Q：What make you think you would be a success in this position？ (你如何知道你能胜任这份工作？）
A：My graduate school training combined with my internship should qualify me for this particular job. I am sure I will be successful. (我在研究所的训练，加上实习工作，使我适合这份工作。我相信我能成功。)
Q：Are you a multi-tasked individual？(你是一位可以同时承担数项工作的人吗？) or Do you work well under stress or pressure？(你能承受工作上的压力吗?)
A：Yes, I think so. A：The trait is needed in my current（or previous) position and I know I can handle it well. (这种特点就是我目前（先前）工作所需要的，我知道我能应付自如。)
英语面试常见问题(2)
Q：What is your strongest trait(s)？(你个性上最大的特点是什么？)
A：Helpfulness and caring.（乐于助人和关心他人。）
A：Adaptability and sense of humor.（适应能力和幽默感。）
A：Cheerfulness and friendliness.（乐观和友爱。）
Q： How would your friends or colleagues describe you？（你的朋友或同事怎样形容你？） A： (pause a few seconds) (稍等几秒钟再答，表示慎重考虑。) They say Mr. Chen is an honest, hardworking and responsible man who deeply cares for his family and friends. (他们说陈先生是位诚实、工作努力，负责任的人，他对家庭和朋友都很关心。) A：They say Mr. Chen is a friendly, sensitive, caring and determined person. (他们说陈先生是位很友好、敏感、关心他人和有决心的人。)
Q：What personality traits do you admire？(你欣赏哪种性格的人？) A： (I admire a person who is）honest, flexible and easy-going. (诚实、不死板而且容易相处的人。) A： (I like) people who possess the "can do" spirit. (有"实际行动"的人。)
Q：What leadership qualities did you develop as an administrative personnel？(作为行政人员，你有什么样的领导才能？) A：I feel that learning how to motivate people and to work together as a team will be the major goal of my leadership. (我觉得学习如何把人们的积极性调动起来，以及如何配合协同的团队精神，是我行政工作的主要目标。) A：I have refined my management style by using an open-door policy. (我以开放式的政策，改进我的行政管理方式。)
Q：How do you normally handle criticism？(你通常如何处理别人的批评？) A：Silence is golden. Just don't say anything; otherwise the situation could become worse. I do, however, accept constructive criticism. (沉默是金。不必说什么，否则情况更糟，不过我会接受建设性的批评。) A：When we cool off, we will discuss it later. (我会等大家冷静下来再讨论。)
Q： What do you find frustrating in a work situation？(在工作中，什么事令你不高兴？) A： Sometimes, the narrow-minded people make me frustrated. (胸襟狭窄的人，有时使我泄气。) A：Minds that are not receptive to new ideas. (不能接受新思想的那些取。)
Q：How do you handle your conflict with your colleagues in your work? (你如何处理与同事在工作中的意见不和？) A：I will try to present my ideas in a more clear and civilized manner in order to get my points across. (我要以更清楚文明的方式，提出我的看法，使对方了解我的观点。)
Q：How do you handle your failure？(你怎样对待自己的失败？) A： None of us was born "perfect". I am sure I will be given a second chance to correct my mistake.（我们大家生来都不是十全十美的，我相信我有第二个机会改正我的错误。)
外企面试英语的常见问题 Tell us about yourself. 这是一个有关你个性、背景、学习以及工作经历的非常宽泛的问题。你可以准备一个简洁的回答。
Why should we hire you？ 招聘者正在问有关你的特点和强项的问题。当然，对求职的公司也要有所了解，你的加入要给对方带来效益才好。
Why did you leave your last job？ 面试人员想要知道你是辞职的，还是被辞退的，或是下岗的，并希望了解原因。你最好实话实说，职场讲究诚信。
Are you willing to relocate？ 这代表着你是否愿意移居另一个城市或国家。
Tell me about your scholastic record. 这是指你在学校及大学所学的学科和成绩。
Tell me about your extracurricular activities and interests. 这是在问你业余都做些什么和你的兴趣，例如运动、音乐或旅游等。一个热爱生活的人也会以很好的热情投入工作。现在，很多企业都比较注意了解求职者的爱好，从外围来考察一个人的综合素质。
How would your last boss describe you？ 这句话的意思是你的上个老板是如何看待你的。最好作客观陈述，包括前任老板对你的工作和为人的评价。
What salary are you expecting？
