Regulatory Scientist

12/2019 – 12/2022

Responsibilities included being the main contact for certain pharmaceutical products within pulmonary hypertension therapeutic area. Involvement with the input in development, post-approval, and life cycle management as well as implementing global strategies. Effective interaction with regional groups and local operating companies was essential to satisfy local requirements for submissions. Additionally, I functioned as the primary global contact for all health authority queries for assigned products. Efficient collaboration across stakeholders and local operating companies is needed to meet timelines, provide satisfactory responses while maintaining company position across all queries. Overall operational support is provided for marketing authorization applications, renewals, and variations. Further, for initial marketing applications I was responsible for modules 1,2,4, and 5 in conjunction with reviewing and providing quality control.

Enterprise project management (EPM), Powerapps, Motivation Projektteams, Projektleitung / Teamleitung (IT), Regulatory Affairs

12/2015 – 8/2019

I have specialised experience in neurology with the following conditions: Mild Cognitive Impairment, Alzheimer's Disease (mild-severe), Dementia with Lewy Bodies, Irregular Sleep Wake Rhythm Disorder due to Alzheimer's Disease, Parkinson's Disease and Migraines. Main responsibilities include the careful consideration of patients along with their medical history to determine which clinical research study they would be most appropriate for as well as closely monitoring their care throughout the study, medication interactions, side effects, and administering cognitive testing. Additionally, a lot of time is spent getting to know the patient one on one to provide compassionate care. Further, I have experience as a psychometrician administering cognitive testing such as MMSE, MOCA, CDR, ISLT, CBB, ADAS. Also, I collect vital signs, perform ECGs, phlebotomy, and process biological samples.

Forschung & Entwicklung, Medizinische Versorgung, Gute Klinische Praxis, Klinische Forschung, Neurologie