Frederik Flindt Kreiner Email & Phone Number

Copenhagen, Dk

Søborg

- Author (lead- or co-) on multiple scientific publications (reviews and original data).- Principal medical writing support to SVP and other senior experts.- Support and planning of strategic portfolio-wide advisory boards with world-leading key opinion leaders in collaboration with SVP and internal senior specialists and VPs.- Authoring of and driving support to strategic articles (original preclinical and clinical research, and reviews), all successfully published in major journals. Written independently and/or in collaboration with internal senior medical/scientific experts and external KOLs.- Authoring of in-house company-wide newsletters (scientific/medical)- Authoring of content for various platforms (scientific/medical)- Ad hoc support to SVP and area

- Intimately involved in ensuring swift US and EU approval of Rybelsus. Responsible for key responses in the Questions & Answers phase.- Submission of the NDA, MAA and more. Appraised components, including the Clinical Overview, which I wrote. Completed in record time.- Responsible for key components (Clinical Overview, pre-NDA packages, label text, phase 3a CTRs and more) of the submission dossier for the largest ever clinical development programme at Novo Nordisk.- Driver and co-author of special publications- Advanced data science, using e.g. Python programming (Pandas, Numpy, NLTK)- Skill area expert in a multitude of IT platforms, including SAS JMP (Clinical), PleaseReview and all relevant software. Advanced programming for analysing clinical data (STDM, ADAM).

Intimately involved in the planning, conduct and upcoming reporting of the clinical trials (phase 1-3) in the development programme for Novo Nordisk's oral GLP-1 candidate.Doing that, I am enjoying myself in a team of very talented and amicable colleagues of all relevant skill areas.Day-to-day and longer term tasks require me to master the medical, statistical, regulatory, pharmacovigilance, linguistic and project management disciplines at the highest level.Other key tasks include exploiting my advanced IT skills e.g. navigating and analyzing massive ADaM/STDM clinical trial data sets using SAS GUI-wise and programmatically.

Copenhagen Area, Denmark

Selected tasks:- Label negotiations- Label updates- Clinical study reports- Clinical summaries- EMA, Australia and Canada HA Q&A responses- Articles (high impact journals)- Conference abstracts- Benefits risks assessments

Allerød, Capital Region, Denmark

Copenhagen

Advanced clinical and translational research, including randomized clinical trials. Continuing my research in chronic inflammatory diseases, I perform front-line, invasive clinical experiments as well as advanced biochemical analysis of the collected samples.

Copenhagen

PhD student (integrated/combined master's and and PhD project). Clinical research in a rheumatic disease of the elderly. Multidisciplinary and comprehensive study using physiological, molecular and clinical research tools. The study included a successfully completed randomized clinical trial (RCT) of a potential new treatment for the disease. A total of 5 papers, all published in high-impact journals and with unusually few co-authors, resulted from the studies.

Copenhagen Area, Capital Region, Denmark

No-nonsense, manual work in a non-academical, yet rewarding everyday setting.

Phd, Biomedicine (Inflammation, Rheumatology)

For my integrated Master's and PhD studies, as one in two out of several applicants, I had the privilege of having the full responsibility.

Msc, Human Biology

Human Biology is an elite biomedical programme at the Universty of Copenhagen that trains the carefully recruited students (30 per year).

Bsc, Molecular Biology

Elite Courses In Alpine Skiing And Mountaineering

High School, High School/Secondary Diplomas And Certificates