My name is Sven and in this blog entry I will talk about my career path and challenges that I had to face throughout my time at Bayer. My career at Bayer started in 1995 as a vocational trainee at Jenapharm. My journey to where I am today, working in Global Regulatory Operations, began with becoming a Chemistry Laboratory Assistant. In 2004 I graduated in Business Administration from the Administration and Economics Academy in Gera / Germany and I received the title Master of Science (MSc), EU Regulatory Affairs at the Danube University Krems / Austria in 2013. Part of my first everyday job consisted of scaling the most daunting regulatory submissions.
One of the most challenging projects that I faced was the record-breaking U.S. submission for a new oral contraceptive for the prevention of pregnancy. This massive time consuming submission consisted of 153 clinical study reports, nine protocols, 42 post-marketing reports, 1,007 references, 1,221 case report forms and the writing, scanning and formatting of more than 6,600 PDF and Word files.
With this project I got to learn that not everything always runs smoothly as a system crash of the publishing tool required my team members to build the electronic dossier almost manually. At the end the final submission took nine hours of transmission time through the U.S. Food and Drug Administration Electronic Submission Gateway, making it one of the most complex eCTD sequences Bayer had ever completed.
Fortunately I had the opportunity to be stationed in Montville, New Jersey in the U.S. between January 2009 and April 2010. Apart from supporting the eCTD lifecycle management for this oral contraceptive I made the most from my stay abroad and took the advice of my employer to spent some time traveling before returning to Berlin. Among my adventures I explored Nova Scotia and Panama city; went whale-watching on the Atlantic Ocean; participated in a 12-kilometer run on the Marine Corps Base in Quantico, VA; joined a cross-country race in Warrensburg, NY; tried dog sledding, horseback riding and shooting; celebrated the July 4th holiday at a spectacular firework display in New York; joined friends in the Catskills for Thanksgiving; spent Christmas in Tikal, Guatemala, and New Year’s Eve in Havana, Cuba.
These were just some highlights from my trip and I will never forget the fabulous 15 months I spent in the U.S. It was incredibly rewarding getting to experience the hospitality of many friends who opened their homes to me.
Where do I stand today? Global Regulatory Operations is basically the last stop before a submission is uploaded for regulatory-authority review. My focus now lays on the Joint Efficiency Initiative which aims at ensuring eSubmission readiness by empowering dossier authors to master the technical requirements of each submission. If they are inadequate or incorrect, the submission will be rejected outright and our timelines become jeopardized. Together with the Global Clinical Learning Academy and colleagues from Global Medical Writing and Clinical Sciences, we developed and implemented an online training program to support authors to get quickly a full view and throughout understanding on the procedures to which they are contributing. Due to the positive feedback we received, the team was able to establish a global network of eSubmission Subject Matter Experts to foster cross-divisional synergies by sharing experiences, ideas and harmonizing our processes.
What do I do outside of work? When I am not working or traveling, you can find me running, shooting or brewing my own beer. I find it important to have a balance outside of work and personally find brewing beer very relaxing as it is a way for me to forget about stress. Remember to always keep in mind: Hoppiness is happiness!
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