Eeva-Maija Walin has worked for 5 years as a Senior Pharmaceutical Chemical (CMC) Expert in Medfiles’ Regulatory Affairs Unit. Eeva-Maija holds a M.Sc. in Chemistry. She has also broadened her expertise by studying pharmacy and microbiology at open universities. Prior to joining Medfiles, Eeva-Maija worked for almost 20 years in various CMC expert tasks in the pharmaceutical industry.
On the occasion of her 5th anniversary at Medfiles, Eeva-Maija describes her tasks and shares her experiences from the past years:
In my work as a Senior Pharmaceutical Chemical Expert at Medfiles, I assist our clients in a variety of drug development projects. I write for CMC documentation for new marketing authorisations and individual variation applications submitted to the EU medicines authorities and the FDA. I have written quality summaries and evaluated documentation submitted by clients against regulatory guidelines (gap analysis). Because of my background, I have also done QA work and advised on GMP related issues.
I no longer work in laboratories or in production, but I analyse, evaluate and produce written material. At the moment, I work almost entirely remotely from home by choice. But I will start to visit my new office in the centre of Tampere from time to time. During the working day there will be a lot of video contacts and occasional on-site visits to clients.
Although compared to working in a laboratory and production environment, ‘just working on the main desk’ sounds monotonous, one of the most interesting aspects of my job is its variety: I meet new clients, diverse products and surprising and varied tasks. There are constant opportunities to take on different challenges and expand my expertise into a range of dosage forms and therapeutic areas in both animal and human pharmaceuticals.
A certain unpredictability in the nature of work can cause uncertainty. I have found that in addition to strong skills, a consultant’s work also benefits from flexibility and adaptability. However, my work is based on longer projects and client relationships, so variety seems to be something that can only bring joy to the job.
One of the big advantages of my current job is the opportunity to influence the content and direction of my work. Keeping abreast of developments in the sector is a prerequisite for maintaining professional skills. I can influence the areas in which I would like to deepen my knowledge. In a company of compact size, everyone has the responsibility and power to participate in internal development and thus influence the way work is done.
I have to admit that while consulting has broadened my knowledge base, it comes with the trade-off of not always having the depth of expertise in a narrower area that I had in my earlier career. It can sometimes feel less satisfying compared to expertise in a single dosage form or product type. However, the breadth of knowledge I have mastered has made me a more well-rounded professional.
My work is very independent and requires the ability to lead myself. However, it can sometimes be lonely without the daily personal interaction of an office environment. Medfiles has an extensive internal network of experts to consult and an external network of collaborators that has been a great support system. In tight situations, Medfiles has not been left to cope alone, but teammates have stepped up to help get the job done on time – having knowledgeable teammates and a shared commitment to client projects is in the client’s best interest, as well as the employee’s!
At the risk of sounding like a consultant, let me say that ultimately the most rewarding part of my job is helping clients achieve their goals. The best feedback is the satisfied clients who return time and time again. A client’s approval of a sales permit or a successfully completed change application is a sincere way to make your own day at work happy. For example, it was nice to come back from holiday today: I had set aside time to start answering any further questions about the variation application I had submitted before my holiday. It had been approved by the authority without any further questions, which is why I had time to write this article.
As I reflect on the past five years, I am grateful for the opportunities this role has provided. The consultancy has broadened my horizons and strengthened my enthusiasm for the pharmaceutical sector. I feel I have many more years of learning and growth ahead of me as a Medfiles professional.
