【编者按】在美国，Civil Servant 与 Public Servant 不同，前者可译为文职人员，后者为公职人员也称公务员。史上Civil（文职）是用来区别Military（军职），但现在文职人员一般是指特殊的公职人员，特殊在他们是因技术特长而被政府雇用的。技术特长是文职人员的本色，但古丽博士强调正直诚信和客观公正的重要性。药品监管，无论是注册审评还是合规检查，都是技术活。但缺乏正直诚信和客观公正监管（文职）人员，无论技术多棒，恐怕都是帮倒忙的。Servant 译为人员，过于平淡，未体现出服务和贡献的意思，但一时也想不出更好、更译为大家接受的译法。技术能力强的人容易在商企中获得高于政府薪水和待遇的工作，但为何要到政府中做文职人员呢？是为个人逐利还是为公众服务？人无完人，但只要有正直诚信和客观公正的操守，或有追求这种操守的意愿和行动，再有激励这种操守和惩罚倒行逆施的制度，也就阿弥陀佛了。古丽博士即将卸任 FDA 驻华办主任，返回 FDA 美国总部任职。她应邀此时给北大 IPEM 和其它学生做一次演讲，内容任她选，不必与药相关。作为科学家，古丽博士的职业生涯中，曾先后承担肿瘤药品审评、全球供应链安保事务、和领导 FDA 驻华办的工作，但是她没有着重讲专业领域，而是选了 Being Civil Servant（如何做好文职人员）这个题目，说明这是她心中想的事、对她是重要的事。让我们一起来分享她的思考和讲说吧。
INTEGRITY, HONESTY, OBJECTIVITY, and IMPARTIALITY。正直诚信和客观公正是所有工作的价值基础。古丽博士分享了她所理解的政府文职人员的准则，并延展到所有的团队工作中去。不仅是FDA，业界也会将这些准则作为核心的价值体系。对工作的认同感除了来源于自我和使命的联结，也来源于整个组织坚持秉承的价值取向和行事原则，是所有“质量文化”的前提。在制药行业，也许每个人的工作不一定都会和产品最终的质量直接相关，但是无论是在研发、生产、质量、监管的各个岗位上，我们的行事准则、工作态度和工作质量，会最终决定交付到患者手中的产品质量，而患者们、亲人和朋友们所能依赖的，就是我们工作中所坚持的正直诚信、客观公正的价值准则。
LEADING PEOPLE AND LEADING CHANGE。领导他人和领导变革。作为资深美国文职人员，古丽博士提到联邦政府考核领导力中最重要的环节：领导他人和领导变革。她分享了自己对于领导力的见解，那就是使每一个团队成员都清楚地了解共同目标和各自角色，以及他们个人能够产生的影响。让下属“遵命”可能并不是最有效的领导方式，让每一个人找到自我价值和工作贡献的契合点，理解自己的工作能有哪些积极的影响，能使所有人都更有干劲。领导变革是每个团队都必不可少的工作，不论是坚持已有的成型的做法，还是向前迈出一步做出改变，都需要整个团队通力合作，理解改变的原因，并且在团队成长的过程中，帮助每一个人实现自我价值。
STRETCH YOUR NEW MUSCLES TO SHIFT。跳出舒适圈，挑战自我。古丽博士在华的两年，恰逢中国制药行业风云改革的两年，她很珍惜在中国学习和接触到的一切，也坦言这对她这个老外是巨大的挑战。除了能够领导周围的同事一起迎接变革、理解工作和自我的价值，她更认为这段经历使她直面转变，活动了从没使用过的肌肉，使她能够以全新的视角来看待整个药品监管和国际供应链的诸多问题。她也鼓励大家，尽可能的跳出舒适圈，哪怕只是小小的一步，都会为自己带来成长，也会使团队更加强大，进而支持每一个人实现更大的价值。
Speech by Dr. Leigh Verbois on IPEM 2017 Commencement July 8th
First, thank you for having me here, it is interesting to stand here and talk about being a civil servant when I am accompanied by people who have served as civil servants for a longer time than I have. Nick and Gang have all come before me, carrying the water that allows me to come in, work hard and enjoy being a civil servant myself. I do want to call that out, that I am not the single civil servant in this room. I would like to express my appreciation for those who have worked hard before me.
Gang gave a good introduction to what my professional life has been. Throughout my schooling and time in US FDA and NIH, one of the things that always struck me is there were a lot of people who came before me, people who recruited me, and people who has expressed to me the importance of working for the government, whether you are working at a local level, or federal level. Without someone coming and describing to me the benefit that I could personally give to the government, whether it is US government or foreign government, I would not have made the career choices that I made.
Making that career choice has been very valuable for me as a person, but I also hope it can be extremely valuable for US citizens. Throughout my career, it has been important to express to people who are also interested in it. I am not getting in front of people to describe rules and regulations, and the impact that I made in a professional way, but to help define why personally doing what I do has meant so much to me. There are many reasons and it is a good conversation for me to have now, because I have been in china for 2 years and I will be departing on August 8. This could probably be the last presentation that I make in China. That is a little bit emotional and hard to do, because we have worked with IPEM for a number of years, and I have tried to engage in a way with deep connection with this community, so that is for this reason if I am emotional.
What I am going to talk about today is why I chose a path to be a civil servant. I mentioned people throughout my career talked about what are the possible benefits of being a civil servant. There were times when I sat in a room, and some people would describe [being a civil servant] in a way that no one would go on to choose to be a civil servant. Some people I met, they would describe in such a rote manner, that it was not possible for the audience to generate the enthusiasm about the world the person claimed. It is important to understand, as a civil servant myself, I feel very CONNECTED to the mission of US FDA. I feel connected to what that mission does to help US citizens. It matters to find those CONNECTIONs whether they are deep threads or fine threads.
When I start to think about what I am going to talk today, I went to the web to determine what the actual definition of “civil servant” is. It says, a civil servant is a person employed in a public sector for a government department or agency. I have to say, the definition embodied the lack of charisma that has been described in some cases of civil servant. To me, being a civil servant is not about being employed by a government agency, it is about embodying the mission of the place you are working for, so that you feel you can be empowered to push the limits and make change. You can push based on what authority is out there, but you are not just riding a tide, you are swimming, surfing and making sure you personally are trying to make a difference. I think the definition of the civil servant given by Wikipedia or Webster is spot on, but in reality, it is not defining what means to individuals as civil servants. I will define the individual civil servants as being able to make those connections, being able to connect to not just themselves but their families and communities. I will give a couple of examples about how I made those connections during my lifetime.
When I interviewed at the US FDA, the director of the office asked why I was making a career path change, because I was going from neurologically focused scientist to a reviewer of oncology applications. It was very easy for me to say, I see the impact that I can have as a scientific reviewer at the US FDA, because I had a family member who passed away within the past 5 years. Throughout my 5 years as a reviewer and 3 years as supervisor on oncology, I could look back and say, we were approving products no matter if I was doing small scientific review or looking at a new drug application to make sure the product got to the market as quickly as possible. I could see a link to a person, to a family member, as you review a drug application, you knew the person on the other end of the application. It is not just a scientific and technical review, and you can make a real emotional call, that there is a patient lying on the bed, without any alternatives. You are one step of the process to make sure the patient will not only get drugs that work, but are also safe. That’s how I connected, I was connected for 8 years on that single piece, that I knew I was helping people in hospitals around the United States and hopefully around the world.
Each career path that I took was critical to me to sit back and understand what the connection to public health truly is. I am not interested in sitting in an office job, and I would say my colleagues are not interested in sitting office where they are not be able to identify the impact they have. I [continually] wanted to play my part, to make sure those around me clearly understood the role they play, and everyone has a story themselves to remind the impact they are making. I am here in China, although in a limited time, but I feel I am making impact to the world, because China is such a critical part of supply chain for the pharmaceuticals, medical devices and food.
It is important for us to make connections with each place we are working, and our colleagues, to understand the role we believe we are playing, so that we help to facilitate the same goal. During my time in China, I have worked very hard to make sure the staff around me in the office understand what the role is, and understand that one little piece – no matter how administrative the little piece is – is to helping provide products to patients, and safe food to consumers. It is not an easy job; it takes time to thinking about what the mission is of our organization, and thinking in a way as an organization.
I have seen people who are willing to move to management, they have the ability to empower the employees, and they have the ability to add charisma to the conversation about the work that you are doing. You can make a narrative for yourself about the impact you are making. It is important to tie it to numbers and metrics, but not allow the metrics to take away what your story is, to make sure the number becomes additive to the story rather than just the only story you have. It is important to have your own story related to the products you are approving, your R&D work, and understand the little niche, then help the people around you to understand the value as explicitly as possible. Because if they do not understand it, they are less likely to do a quality job. I believe people who truly have the connection between the work and the mission, are going to be more engaged and motivated to do a quality job. It is not the pharmaceutical quality per se, but it would be your end outcome. Throughout my career, all of the things that I have done, helping to ensure the availability of oncology drugs, dealing with supply chain integrity issues and helping understand where we can make the most impact in China. These has always gone back to the mission.
In China we recognize there is a fundamental shift and reform happening here and that the US FDA has the ability to have conversations that helped underpin what is going on. We are not the fundamental changers here but we are here to help have conversations about how important it is for us to work together. These conversations are not so different from what would happen in a company. Take that information and understand what you feel you need to portray for your own company, and help build that mentality into your organization. Each person has the ability to do this because you plant seeds and every small conversation can have a ripple effect throughout organizations. One person really does have the ability to ensure that as your company is growing with the right kind of people who truly understand that they are not needed because of their bottom line but to make sure that patients have access.
I did little research about civil servant because while I've been a civil servant for 15 years truly I did not do a lot of indepth analysis of what it meant to be a civil servant or what the underpinning values of being a civil servant were. A great deal of research that I found said that civil servants are underpinned by INTEGRITY, HONESTY, OBJECTIVITY, and IMPARTIALITY. I would say that most organizations that are high quality are underpinned by those values. That setting up an organization that understands quality, and understands the role that they play needs to have these in place. Many of these pieces in my mind actually played right into quality culture, the conversations we've been having for a couple of years. It is about what needs to be in a specific institution to ensure that they are making a high quality product and they're doing it not just based on trying to get something out quickly but they've got it with an underpinning value system that make sure that if problems come up this problem can be dealt with. All of these values – INTEGRITY, HONESTY, OBJECTIVITY, and IMPARTIALITY – play a vital role in that.
INTEGRITY and HONESTY are ensuring that we – whether you are in the US government or you are sitting in a pharmaceutical company – are identifying something and being honest in its representation. You are looking at a holistic problem and you are identifying honestly what plays a role in those problems. OBJECTIVITY and IMPARTIALITY are looking at information in taking yourself out of the situation so that you can scientifically address what's happening. Impartiality is doing it for the better good. Taking it away from your specific company and deciding for the better good that there's a pathway that needs to be taken. So I'd say that I as a regulator have to have these underpinning values, as a civil servant across government organizations, whether I'm at the local level or at the federal level, I need to have these in place. I have to be working not for myself but for the people who I represent, the people who are the end users of the products that I am working on.
As I have gone through my career there's been a great deal of opportunity for me as an individual to obtain professional development, which is extremely valuable for me, because it helped me see things in a way that I would not have been able to see without this training. The training happened in classroom settings such as this, it's happened in the fields where I work with groups, it's happened in my own office with coaches to sit down and talk to me about the specific value and how these values are to help my lead. There are two places we have had opportunity to work on, LEADING PEOPLE and LEADING CHANGE. The federal government have 5 different ways to measure senior leaders and it's important for the senior leaders to understand the impact that they can have. Two of the 5 measures is leading people and leading change.
Leading people is what I talked about before, it is being able to get your organization to understand its mission and be more productive because of that. For me that's what it means, there are other ways in which people lead: some people lead by empowering from the bottom, some people lead by putting structure in from the top. The way for me is that I want everyone in the organization to understand clearly what their role is, and how they make impact to the organization in a positive way.
The second is leading change. Leading change is what China is doing now. China is in a reform period that is enabling them to change the way they are regulating pharmaceutical products and medical products as a whole. Each person in this room has the ability to work on that leading change piece, whether you are leading it from your own organization internally or you are deciding you want to work externally as a government employee. It is important for people to understand that in that leading change, there are small things that they can each individually do to add to the greater good. This can be through facilitating discussions, to ensuring there is a next generation of people who can come in and manage the situation after changes have happened. As a leader, it is important to make sure that we are helping individuals and organizations understand what changes mean to them. [That] there's not heightened periods of anxiety for stakeholders or individuals with the organization and for the government as a whole. Because there are big changes under way and there are many ways in which you as an individual can do. There are ways in which I have worked with in my organization to make sure people clearly understand what the change means to them. I think this is a really interesting piece right now here in China because of the amount of reform that's taking place, and because of the chance that each individual in the sectors that are being reformed have the ability to work really carefully within their organization institute policies and practices that will support stronger organizations in the future.
Without this concerted push for investment in this leading change, organizations become less stable, whether those organizations are government organizations or private industry. If change in the transitions that occur are not managed well, there becomes instability. With the chance for organizations to put stability, here is another place for quality culture can play a role in industry. Once the culture is in place, you can touch back to what that means for your organization specifically. We've been speaking about quality culture for a number of years now and I've been having some conversations with general managers and CEOs. It is interesting to talk to them about the shift within their own institutions and how they implemented their shifts in the time frame that it took. I'm talking about these reforms and talking about instituting processes to help make sure organizations are strong as possible. To find a solution, it does not take a long-term plan. In some cases, you can start with a shorter term planned and understand that in the long term this is your goal.
One thing throughout my career at NIH and US FDA is that I as an individual, have the ability to do something small. The small thing could either be holding my ground, because I feel strongly that issue is important and I'm not willing to deviate or setting a precedent, or, It could be that I think precedent needs to be set. I need to push really hard to make sure my entire organization around me understands why we're doing something different.
It is not easy, it takes a lot of energy. I remember there were periods of times even as someone who gets energized about the works that I do, it would be exhausting. But it was my job. And I began to really understand and ground myself in the idea that it was my job to make sure that we either stood still or we moved forward. I bring this to your attention only because I think there are times for everyone's career where it is necessary to stand still and hold your ground because something is so very important that you're unwilling to budge, or vice versa.
You are on the leading edge of things where we need to bring people around. If you're making a change any deviation on policy or practice, it is quite frequently that you do need to work with the group, you're not making decisions by yourself. One of the things that I enjoy about being a civil servant is, as much as I like to lean in and lead organizations, it is my responsibility to make sure people around me agree. It is my responsibility to make sure people understand what the process is because I am not doing something on my own: I am not approving a drug by myself, I'm not making a compliance decision by myself, I don't even really do outreach by myself, we do it as the team. To make sure that everyone understands that the work that we're doing is being done for a specific reason, and having that approach work you have a team around you makes those decisions stronger, and more likely to be engaged at different levels of organization. It makes you battle to ensure that you are on the right place, that your decision is grounded in science at FDA. When you have a group of people around you who are technically savvy, who are willing to push back on you, because you don't want someone who's just going to be a yes man, your decisions are going to be so much stronger. One of the important things for me to be a civil servant is that you were not working alone, but as a part of the organization and you can see that the network of your organization spidering out so that you can see the results.
Now there are times where it takes great leaps to see the result. There are times when you're sitting in your office and reviewing packages, talking about a compliance action. While you need to stop and look at what the end outcome is, what are you trying to achieve. Once you understand what you are trying to achieve it becomes such a stronger effort to begin with, and you can put in a lot more energy.
This time in China has been the culmination of what I have talked about in terms of leading change, leading people, building organizations that are honest, have integrity, objectivity and impartiality. As we grow, as every organization grows, when reforms and change happen, it's important to just go back and think about what you have done and what your end goal is. The time in China has been amazing. It's been more than I could have wanted, [which I wanted] for almost a decade before I got here. China has been professionally and personally, a challenge for me, and those challenges have made me grow in being a civil servant for the US FDA. I am looking forward to taking everything that I learned, in spite of the fact that I did think I was going to be here for 6 years and I am only going to be here for 2. I am looking forward to taking all of that back with me to the US FDA and Washington and making my organization that I am working with stronger, because I know things and I have experienced things in a different way. China has been perfect for that, because you cannot help but go out to have a little adventure, and stretch muscles you
have not been using, so that you can be successful here. I encourage everyone whether you are taking the path of going into an industry office, or you are deciding that you want to shift gears and do something different. Stretch your muscles and challenge yourself, because in the end, it will make you stronger and it will make that next place you go stronger every single time. Thank you so much!
