Spotlight: Kolabtree’s Regulatory Medical Writer Dr. Nare Simonyan

Kolabtree'.s freelance scientist and regulatory escritor médico Dr. Nare Simonyan sat down with us for an insightful chat on various topics, such as her freelancing journey, areas of scientific expertise, how she provides value as an on-demand consultor de regulamentação to drug products and dispositivo médico companies, and where she thinks remote consultoria científica is heading.

Check out more of our Destaque interviews with freelance scientists. 

Dr. Nare Simonyan is one of Kolabtree's top regulatory escritores médicos and independent consultants. With a PhD in pharmaceutical science, she holds over ten years of experience across myriad subject areas, such as assuntos regulatórios, consultoria em ensaios clínicos e escrita médica.

In over 2 years as an independent consultant on the Kolabtree platform, she has written manuscripts and articles for pharmaceutical and saúde industries and handled over 40 clients. 

Naren Madan (Kolabtree): Tell us a bit about your career and freelancing journey as a regulatory medical writer.

Nare Simonyan: I’m a pharmacist with over ten years of experience, before getting into escrita médica and clinical trial consulting. I strongly believe that access to healthcare information can improve people’s lives, and this is possible only when we disseminate the correct information in a form that is easy to read and comprehend. These reasons inspired me to get into medical writing. 

I came across Kolabtree on LinkedIn 2 years ago and decided to join it immediately after reading great reviews from freelancers and clients.

NM: Brilliant. In these 2 years, what are the differences you’ve noticed between working full-time and freelance consulting?

NS: Well,  the foremost reason for my gradual shift to freelancing was flexibility. I think timing was also a factor, since the pandemic ascertained that freelance work was the only way out of the job crisis at the time.

Another significant advantage of freelancing is your ability to focus better on a singular project, such as maybe one type of escrita médica ou redação regulamentar. Your stress levels are tremendously reduced since you control your schedule and the projects you take up. Also, your work is highly project and skill specific. You do not have to juggle other responsibilities and additional work, which full-time hires are expected to do.  

Location independence is another main factor for the boom in freelance work. The ability to work from anywhere and anytime helps with an increase in productivity. 

NM: Can you give us some insight on the kind of projects you take up on Kolabtree?

NS:  In my two years as an independent scientist on the platform, I have worked with more than 40 clients. The projects I usually take up are pretty diverse in nature. For instance, I have written more than 30 articles and manuscripts for different companies. I have prepared an application for authorization of medical products to align with the regulations and compliances of countries such as the USA, EU, and Canada. 

I have also edited and proofread medical, scientific, and academic documents, and partaken in scientific and technical consulting. So far, my biggest accomplishment through Kolabtree  has been creating a proposta de subsídio for submission to the US health authority.

All in all, I’d say freelance work has enhanced my learning curve immensely by exposing me to various projects. The curve is not without its ups and downs, of course. One of the biggest challenges I face is writing an article based on a clinical trial conducted by clients. These experiences, in fact, are what makes freelance consulting an interesting life choice.

 NM: What process have you adopted to optimize your project selection on Kolabtree, especially when it comes to ensuring client information security and confidentiality? 

NS: Generally, I work based on the guidance provided by the Kolabtree team within the platform. A highly beneficial facility is the availability of a predefined agreement, which every freelancer has to sign upon joining the platform. The agreement has helped me with client communication and maintaining data confidentiality.

The pre-defined agreement has many critical country-specific legal points, which have played a crucial role when dealing with clients from different countries. This sets the tone for data exchange, and ensures that data confidentiality is guaranteed before the client sends sensitive information about the project to me.

NM: You take up loads of highly redação técnica projects. What can you tell us in terms of how you approach such projects?

NS: Como um consultor de ensaios clínicos, I mostly write technical material revolving around the clinical trial data provided by the client. I understand and analyze the data, then proceed to improve and cleanse the data to write articles or transcripts as requested by clients. No two projects are the same, and these intricacies and subtle differences add to the variety that freelance consultants get to experience in their day-to-day lives. 

 NM: How do you think the pandemic influenced remote work, freelancing and the benefits of hybrid teams?

 NS: I definitely think the influence has been massive. I worked in a traditional office before the pandemic, and used to have a presence only on LinkedIn, which is where I stumbled upon Kolabtree during the lockdown. Like I mentioned before, the pandemic definitely accelerated the shift towards remote work and increase in freelancing amongst academics and scientists. I think companies are also starting to realize the efficiency of outsourcing projects to freelance scientists, which can help them save money and test out ideas in a very flexible and cost-effective manner.

 NM: Tell us about some projects as a regulatory medical writer that you’ve found challenging and exciting.

NS: I am a conformidade regulamentar specialist; I also have expertise in preparing common technical documents (CTD) for medical products, which allows clients to submit for package authorization with health authorities. I also specialize in creating an electronic version of such CTDs. The biggest challenge I face on a regular basis is to fulfill regulatory compliance for clients’ businesses in different countries. The regulations and policies of various countries vary, and a deep study is required to satisfy clients’ requirements, keeping me on my toes each time I engage in such projects.

 NM: How has the experience of working with clients spread across different geographic locations been?

NS: Ah yes, that’s a massive challenge. Coordinating with clients working in different time zones, especially with the big time difference between USA, Canada etc; matching schedules with clients in such cases is trouble. 

Another complicated task is understanding the requests of various clients and the specific tasks they want to accomplish. I’d say this is the most important part of freelancing. Once you grasp the intricacies of what a particular client really wants, it’s pretty much easy sailing from there. Sometimes, the client might have an idea and not be really sure of how to accomplish it, so multiple meetings might be important before you start working on the task.

 NM: Any tips on how a freelancer can get started and find relevant projects on Kolabtree? 

NS:  It’s imperative to write effective proposals, I’d say that’s the most important part of scouting projects. The proposal should discuss your qualifications, education, previous work experience, and accomplishment. Also, ask more questions to clients on the requested project. 

Another critical factor is to assess if the project falls in your area of expertise. Clients often reject you because you need to be better suited for their requirements. Your expertise may be required elsewhere. Thus, positioning your field of specialization is essential. For example, I have displayed my expertise in regulatory, medical writing, and literature pesquisa, so I only attract clients with requirements in these areas. 

Such clear distinctions will help you find relevant projects, and it’s smooth sailing once you set the ball rolling. 

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