An Interview with Orit Scharf: How I became a Medical Writer

by: Astha Jaiswal

Astha Jaiswal spoke with Orit Scharf, Associate Director, R&D Science Submission Management at MedImmune. Orit carries years of experience in scientific and medical writing. We asked her about her journey in this field and gathered her thoughts on challenges and opportunities in the industry.

  1. Could you tell me a little about your career path and how you reached the current position at MedImmune?

I did an undergraduate degree in biology, followed by Master’s in Biochemistry and PhD in Immunology/ Biochemistry area. After that, I did my Post-Doctoral research at the FDA at the Division of Hematology for 3 years. At that point, I realized that I wanted to move away from bench roles and do something outside of the lab. At the time, there was a series of lectures at the NIH for Post-Doctoral fellows regarding ‘Alternatives Career in Science’. Every lecture was taken by people from different fields. When you are in the lab, you don’t think there are all these options available. So attending this series of lectures opened up a lot of ideas. There were people from regulatory, commercial, and other areas where scientists end up when they are not in the lab. After my Post-Doc, I was looking for jobs and this opportunity came for a medical writing position at a company that was contracting the regulatory writing for the NCI (National Cancer Institute). I joined that position and learned a lot in the five years that I was there. It was the best school. We had interactions with NCI physicians, meeting with drug companies that were sponsoring trials, and regulators. After that, I got into MedImmune, in the CMC (Chemistry, Manufacturing and Controls) writing group. MedImmune was a great opportunity because it was a new group that had not been in place before. It was really a chance for me to carve out what I wanted it to be.

  1. What is it like to work in the area or scientific/ medical writing and the industry in general?

When I decided that I wanted to move away from bench roles, the idea was to see what else is out there. You see all this research, discover new things and do experiments, but what happens after that? How do people use these new discoveries? So what I like about scientific writing is that it is something which is still close to the science in the lab, but I see it as a middleman between science and the approval of a new medicine. I am not doing the science myself, but I can read about it and still get that connection. Also, I personally really like writing and I enjoy that part a lot. I like the fact that what we do is a bridge between lab and delivering that to something that will end up as a drug/medicine for patients. For me, it kind of brings out the pieces together to something that I really enjoy doing.

  1. What are some of the responsibilities that come along with the role? What traits, skills, or experiences do employers in your field look for in candidates?

In these positions, it is important to have people that understand the science, and have a science background because they are often the first people to see the first output that comes out, when physicians who do medical writing write their part and scientists who do scientific writing write theirs. So, a person with that background would be able to interpret what they read, and if need be, they can re-write. I call that translating the science into regulatory. Also, a lot of times in these roles you have to work with different people in different functions. You have to coordinate input from various sources, and put it into one cohesive narrative. Hence, the ability to work cross functionally and connect with different personalities is always important. Then, of course, be able to write well. Sometimes scientists are good but their writing skills may not be so great and they need help with that; so you are required to turn what they wrote initially into more clear and fluent language. Often regulatory documents have many contributors in a section and you have to make it look like one cohesive section. Also, you need to know the regulations, what are the requirements for these documents, and regulatory guidance. So, there are a lot of different disciplines that scientific/ medical writers have to generate.

  1. What are some ways that other people you know have entered in this field? What career options people can have after leaving such a position?

In the previous company I worked for, that actually had an assortment of different people. You hear that story a lot, that people work in the lab and they don’t want do that anymore. A lot of them were post-docs. People went to different roles from there. For instance, one colleague did a part-time MBA program along with that job and then went on to work for a venture capital company that assess biotech companies, so she used her skills there. A lot of people go to regulatory or from regulatory to medical writing. One person actually went back to work in the lab after being a medical writer for the longest time. At MedImmune, many of the medical writers moved to the clinical scientist group. Project Management is another area where you can make use of similar skillset. So, I think there are lots of possibilities. Also, people come from different backgrounds with different levels of education- undergraduate, graduate, post-doc. It depends on when they take the decision that the bench is enough. Today you can have a degree in regulatory sciences, a field that has not been around for the longest time. Education wise, there are more people with education in a regulatory field, which is great and they come with a background with it instead of bumping into the field. There are a lot more resources for people who want to pursue that defined career path. If they decide early, they can actually acquire some education and learn skills that they otherwise would have learned on the job. So, they can actually be more prepared when they get to the job.

  1. What according to you is the most challenging aspect of working in this area?

The most challenging aspect is the cross-functional work. You have to really deal with a lot of opinionated and smart people that feel very strongly about certain things. They don’t always agree amongst themselves. They are usually stakeholders for the work that you do or contributors. Sometimes there are conflicts and you have to manage all of that. Ultimately, you have to put the document together. So, you really need to manage the diversity of opinions and different personalities react in different ways. Managing that is challenging, but I enjoy that part too, because it gives me satisfaction when I succeed and at the end everybody is in agreement. I always enjoy seeing that.

Another aspect of the work is that it takes a long time to get a drug out there. You might be working on something for several years, and all of a sudden for any reason such as commercial reasons, toxicity event etc., the development of you drug may be stopped. That could be frustrating at times because you put in a lot of work and you wanted to succeed but it just goes away. Overall, this is a good place to be in in the sense that you do the science and you are a part of the process that brings the drugs out to the market and patients. So that is the fun part of it.

  1. Any word of advice for PhD students and postdocs who aspire to transition from lab to industry

There a lot of positions out there and sometimes they ask for experience, and you don’t have it if you are right out of school. So there is always the question of how do u get in? If there is an opportunity to get into some of these positions even if it is not in the role you want, but there is a potential to grow and to move around within the company, it is one route. You can always transition in a couple of years. Even at MedImmune, a lot of people work in the lab and then move into writing, regulatory, project management or other areas. I have also seen people work in one position and carve out their own time, and intern in another area of a company to gain other skills. They either then transition in the same company or move to another place for a full-time role in the skills they acquired. Just keep your eyes open for any opportunities. Sometimes it may not be what you want initially but it can lead there, as it is not easy to find dream jobs right away.


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