Name: Juliane Lessard, PhD

Job Title & Company: Biologist, FDA, Center for Devices and Radiological Health

Location: White Oak, MD

How long you’ve been in your current job: 1 year

Postdoc Advisor, IC: Dr. Maria Morasso, NIAMS

What do you do as a Biologist?
I mostly review pre-market regulatory submissions for in vitro diagnostic tests, which are considered medical devices. My division gets many different types of pre-market submissions (e.g., PMA, 510k) depending on the type of device and the type of test. My supervisor will assign me a submission and I then begin the review process. I work with product specialists, other reviewers in the division, and management to get a good idea of what we need, evaluate performance data to identify any potential safety issues, and determine what we should ask the industry sponsor to provide for us in order to complete the review. I also interact with the industry sponsor directly to clarify issues, request updates to the material, etc. Within a pre-determined time frame, we will decide whether the submission contains any deficiencies too significant for us to continue our review at that time. If so, we issue a hold letter with a list of items that the sponsor needs to address in order for us to continue our review. Or, if there are no deficiencies, I recommend approval or clearance of the submission and if management is in agreement, the sponsor can go ahead and market their product.

What are the most important skills that you utilize in your current position?
I do a lot of reading and a lot of writing. There are memos for everything and because I interact with the industry sponsors directly, it is very important to be able to write clearly. There is a highly specific way to write in regulatory affairs, which was a pretty steep learning curve for me coming to the FDA. I read probably a couple of hundred pages a day. It can be easy to get lost in the details, so it is really important to be able to extract the important points from a submission while keeping the big picture in mind. I would say this is very similar to manuscript reviewing for publication in journals.

How did you get up to speed on the regulatory affairs writing style?
The way it is done in my division (and in most other offices at the FDA), I was assigned a mentor who was different from my direct supervisor. In the beginning, that mentor worked with me on all of my submissions. She would edit my language and offer suggestions on how to word things. She would also provide examples for me to look at how certain issues had been addressed previously. This mentor worked closely with me for the first six months and my direct supervisor would meet with me every other week to go over any transition issues. In addition, I completed several months of coursework as part of the Reviewer Certification Program, which is a requirement for new reviewers in the Center for Devices and Radiological Health.

Other than the writing style, what has been the hardest aspect about transitioning into this career?
One of the hardest things to adjust to was the amount of reading that I do. I also sit in front of a computer all day. There is no getting up and doing experiments and then sitting back down. A lot of the work is very deadline driven. This wasn’t a problem in the beginning, but now that I have more parallel submissions to work on, it is very important to schedule my timelines well. In the lab, I could just do an experiment next week or not look at it for another month, so my current work is a lot less flexible than time management in the lab.

What is your favorite aspect of your current job?
I really love how diverse the work is and how relevant it is to public health. It is very rewarding for me to know that my work has a much more immediate impact than what I was working on when I was on the research side at the NIH. For example, I can go to the drug store and see some of the over the counter devices that we regulate. Our division reviews pregnancy tests, so when I see those, I think, “Oh, look at that – I am part of the pathway for this product to be on the market in the US!”

What was your job search like?
It started when I met with OITE pretty early on during my postdoc. I did all of those personality tests, but what really helped me was Science Career’s IDP. I knew I didn’t want to go into academia and I was looking for something that was a little more family friendly. One of the top hits from the IDP report was in Quality Assurance and Regulatory Affairs, and I didn’t know anything about it really. Then I remembered that I had met somebody from the FDA when I was in grad school. I looked her up and found out that she was still at the FDA. She invited me to come over to see the office for an informational interview and she gave me a couple more people to talk to. I started doing a lot of informational interviews in this area. I also used LinkedIn and found several alums not only from grad school but also from my college who now work as regulatory reviewers at the FDA. Most people were really willing to talk on the phone or in person for a couple of minutes. I made up a short questionnaire so I could ask everybody similar questions.

Eventually, one of my informational interviewees showed my resume to her supervisor and I was invited for an interview. I was originally hired as a Staff Fellow, which is a Title 42 direct hire position. After I had my interview, I had to submit a formal application for this position. A Staff Fellow is term-limited (for two years), so I continued applying for review positions in my division through USAJobs after I started at the FDA. After a few tries, I was successful and my Staff Fellow appointment was converted to a more permanent (GS) position as a Biologist.

What resume tips can you share?
One of the things I learned from my informational interviews was to highlight the following skills: time management, critical thinking, writing skills, presentation skills, and team work. For my resume, I tried to incorporate most of these skills into my qualifications summary on my resume. It also helped to highlight a lot of manuscript review experience because that is very similar to pre-market review work at the FDA.

What was your interview like?
It was a group interview. The way our division is structured is that we have several branch chiefs, kind of like lab heads. All of the branch chiefs were there. It was mostly based on my resume and they asked me questions on my background and what kind of lab techniques I was trained in, as well as questions on how I manage my time and why I wanted to work at the FDA. Overall, pretty standard questions and it was only a one round interview.

You have to have a lot of patience with the government hiring process, even with Title 42. For me, I interviewed in May and didn’t hear officially that I was going to be hired until the end of September. I have heard from others that generally the process takes about four months after a successful interview.

You did a lot of research and informational interviews about this field. Now that you are in it, is this work what you anticipated? Any surprises?
The type of work was expected, but the details weren’t. I didn’t realize how many different types of submissions we would get. There is a really big span from engineering to clinical trials to basic chemistry.

In hindsight, would you have done anything differently in your job search?
I would have started earlier. The postdoc helped in terms of the work experience, but not in terms of the technical knowledge. Part of me wishes I had explored this career option in graduate school in more detail.

For somebody, hoping to go down a similar path, do you have any last bits of advice?
My advice to others is to start early because it can take a long time to find an opening and to find somebody who needs a reviewer. Plus, it takes a while to get through the hiring process.

OITE’s new Career Options Series will give you a snapshot overview of different career paths. The goal of this blog series is to help you explore a variety of different options by connecting you to new resources. A large part of making a good career decision is done by gathering information about that field. We encourage you to follow up this online research by conducting informational interviews with individuals in each field.

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What is Public Health? “Public Health is the science of protecting and improving the health of communities through education, promotion of healthy lifestyles, and research for disease and injury prevention. Public health professionals analyze the effect on health of genetics, personal choice and the environment in order to develop programs that protect the health of your family and community.” - From the resource: www.whatispublichealth.org Sample Job Titles Global Health Specialist; Public Health Analyst; Field Support Manager; Public Health Director; Health Policy Analyst; Regional HIV/AIDS Technical Advisor; Program Associate; Program Officer for Africa, East Asia, etc; Health Policy Consultant; Nutrition/Sanitation/ Maternal Health Specialist; Proposal Writer; Health Coordinator; Field Organizer; Project Manager; Advocacy Officer; Consultant; Program Analyst; Public Health Associate; Regional Specialist, and many more. Sample Work Settings Government Agencies; Government Contractors; Intergovernmental or Multi-Lateral Agencies; Non-governmental (NGO) agencies or Non-Profits; Private Sector such as consulting firms or lending agencies; Think Tanks; In-Country/Disaster Relief Sample Employers Abt Associates ACDI/VOCA Advocates for Youth American Red Cross Bill and Melinda Gates Foundation CDC Devex Department of State Doctors of the World EngenderHealth Family Health International Human Rights Watch ICF International Kaiser Foundation NIH Peace Corps Public Health Institute United Nations UNESCO UNFPA UNICEF USAID World Health Organization World Vision Potential Topics/Areas of Specialty • Biostatistics and Informatics • Community Health • Capacity building • Communicable Diseases • Consulting • Emerging economies • Environmental Health • Epidemiology • Global Health • Grants management • Health Administration • HIV/AIDS • Infectious diseases • Migration & Quarantine • Neglected diseases • Program evaluation • Policy • Reproductive health • Social and Behavioral Health • Vaccines • Vulnerable Populations • Water, Sanitation & Hygiene Key Skills - Communication, both written and verbal - Language Skills -- proficiency in Spanish, French, Arabic, Chinese, etc - Analysis and Evaluation - Project/Time Management - People skills (consensus building) - Cultural Sensitivity - Problem-Solving How to get started • Fellowships e.g., USAID Global Health Fellowship • Internships e.g., NCI Health Communications Internship • Details e.g., NIH institutes; 1 day/week • Networking e.g., With speakers at NIH global health seminars • Volunteering e.g., Global Health charities, here and abroad • Additional education/degrees (Masters in Public Health) • Certificates (Certificate in Public Health –FAES) Professional Organizations American Public Health Association Global Health Council WFPHA Additional Resources OITE’s How To Series: Global Health Guide to Public Health Careers Explore Public Health Careers Schools of Public Health Application Service ……… Coming up in the Career Options Series, we will be highlighting the field of Science Policy.

This From the Archive post revisits a decision many individuals struggle with. Should I stay in academia or should I go into industry?  According to a 2015 Nature survey, graduate students dream of academia but are keeping their career options open.  According to Nature, "The survey also revealed uncertainty and ambivalence. More than 60% of respondents said that they are “likely” or “very likely” to pursue a job in industry (see 'Industry appeal'). And 61% said that they are “likely” or “very likely” to pursue a research job with a government or foundation, which makes it clear that many graduate students are unclear about their futures." Science Careers held a webinar on the topic of industry vs academia and the panel discussion included speakers from both fields who took questions from an online audience of postdocs and graduate students. Even though this webinar is a few years old, there are still some very relevant points to keep in mind today.

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Many of you may have asked yourselves this question at some point in your academic careers. Which job would give you the most freedom research-wise? More time with your family or for outside interests? Higher salaries? Job security? 1. What questions should you ask yourself to determine whether academia or industry is the right fit for you?

• Do you want to stay in research or move away from the bench?
• What are your strengths?
• What do you enjoy doing?
• What are you most passionate about?

2. What are some essential differences between academia and industry?

• In academic work, you will be expected to be a self-starter, comfortable with self-promotion, and will largely work independently, developing research questions on your own.
• In industry, you will also be expected to drive yourself, but with a view toward a common goal, and an understanding of what is expected of you as a member of a research team, based on objectives set at the beginning of your employment.

3. How can I learn more about these two worlds?

• Conduct research on the web.
• Talk with people you know in both spheres.
• Attend university or institute career symposia, career fairs, panels, etc.
• Talk with people at scientific meetings.
• Attend any lunches, networking events, etc. after research talks on your campus.
• Ask scientists you meet about their own career paths.

4. When should I start preparing for either job?

• It’s never too early! Even by the 2nd year of your postdoc, you should be updating your CV, participating in skills courses, taking on a summer student – basically doing things that will set you apart from the crowd on the job market.

5. Are there jobs available in industry or academia in this bleak economic climate?

• Yes! There’s never a total hiring freeze in industry, so there are always opportunities for people who are smart, well-trained, and have good ideas.
• In academia, positions may be slightly easier to come by in private institutions, if endowments have rebounded.
• Universities need to maintain research vitality, so hiring will always be a priority.
• One way of uncovering opportunities is to find out which universities are building new science facilities. These institutions will typically need new science faculty to fill new lab space!

6. Which path allows for greater work/life balance?

• This depends on the particular company/institution, particular department, particular job.
• While some may think that schedules are tougher on the academic side, some industry jobs also require a great number of hours during the work week.
• Some may feel a greater sense of freedom and therefore balance on the academic side because the hours are flexible, while others may feel more balance in industry because the hours are more structured.
• This depends largely on the person and the work situation.

7. Does compensation vary greatly from one to the other?

• No, compensation levels are surprisingly similar based on level of experience, promotion, etc.

8. What skills are most important for me to develop before going on the job market?

• Networking is #1, followed by teamwork, and being a thoughtful leader.

9. What are the pros and cons in academia vs. industry?

• Benefits in academia: a sense of autonomy, an excitement around novel discoveries, intrinsic motivators, travel, getting to know people all over the world, collegial environment. Downsides: grant renewal, feeling pressure to publish or perish.
• Benefits in industry: potential benefit to patients of what you’re working on, fairly immediate application of science, access to resources, connections to other scientists around you. Downsides: cannot always investigate areas of personal interest.

10. Any final thoughts, words of wisdom?

• Stay true to yourself, know yourself well before going out on the market.
• Practice what you’re going to say so you do the best job of selling yourself.
• Start early and practice often.

Continue this conversation with professionals you meet in both academia and industry. These interactions will help you to determine what is best for YOU!

It’s the week of Thanksgiving. In the United States, this signifies a time of the year when many of us gather around a large meal with family and friends to not only celebrate, but also to reflect on things in our lives for which we are thankful. Even if you don’t celebrate Thanksgiving, this holiday can be a good reminder to stop and take a moment to be thankful. Studies have shown that cultivating gratitude is beneficial in numerous ways. Being grateful can help crowd out negative emotions, help foster a more positive mental attitude, and positivity has been shown to have huge physical and mental health benefits. Not only can gratitude increase your sense of well-being, it can also play an important role in your professional trajectory. To clarify, we aren’t talking about the standard thank you letters that you send out after interviews or networking events, even though those are great and extremely important to continue sending. Rather, think about sincerely thanking somebody, which requires taking a moment to pause and acknowledge another's assistance or even just to remark on the great work they are doing. Thank you notes not only make the recipient feel good, but it’s also a beneficial exercise for the letter writer. As noted in the article “How thank-you notes can transform your career,” gratitude can be professionally powerful. Take the article’s example of Douglas Conant, the former CEO of Campbell Soup. During his ten years at Campbell, he helped turn the company around – he cut costs and implemented innovative marketing efforts all while improving employees’ engagement levels. How did Conant do all of this? Well, for the latter part, he wrote 30,000 thank you notes. He would take about an hour a day to write 10-20 thank you notes to employees at all levels of the company. He had a staffer help him find success stories to praise. Conant is quoted saying, “We’re trained to find things that are wrong, but I try to celebrate what is right.” His focus on strengths worked to help motivate employees and turn a lagging company around. Mark Zuckerberg, Facebooks’ CEO, took on a gratitude challenge in 2014. Zuckerberg celebrated Facebook’s 10^th anniversary year by writing one thank you note each day. His reasoning was similar to Conant’s and he said, “It’s important for me, because I’m a really critical person. I always kind of see how I want things to be better, and I’m generally not happy with how things are, or the level of service that we’re providing for people, or the quality of the teams that we built.” It can be easy to focus on the negative and dwell on what isn’t going right. In order to cultivate gratitude, we recommend an activity which was previously discussed in a blog post about enhancing optimism and resilience. During Thanksgiving, try this out: Gratitude Visit and Letter Close your eyes for a moment and think about a person who helped you out in the past. Perhaps someone you never properly thanked? This is a great activity to help you feel more positive because when you feel grateful, you conjure up a pleasant memory or association. Then, expressing that gratitude can help strengthen your relationship and can create more positive connections.   So, give that person a call, write them an e-mail or even drop by their office or home to say thank you! If you try this activity out, comment and let us know. Thank you, dear readers, for continuing to follow and contribute to this blog!