About
Summary
Now I like to make use from more than 25 years of experience, knowledge and methodology in R&D and regulatory medical writing as a physician at the pharmaceutical industry.
I am looking for R&D related to epigenetics, immunology, microbiology and neurology with a PhD option. Here I expect challenging results on diseases like fibromyalgia, CFS and chronic arthritis.
Positions
Senior Medical Affairs Manager Apr 2013 -
Since 2011, writing, substantially contributing to and reviewing stand alone or in co-operation with external consultants a total of more than 750 medical-pharmacological expert documents for regulatory competent authorities across EU and worldwide for the application and maintenance of drug marketing authorisations, such as
Clinical (CO) / Nonclinical Overview (NCO), Addendum CO (ADD-CO), Clinical (CES) / Nonclinical Expert Statement(NCES), Bioequivalence (BE) Waiver, Company Core Data Sheet (CCDS), Core Safety Profile (CSP), Common Technical Document Clinical Summary (CTD2.7) and Nonclinical Summaries (CTD2.6), Literature search (Lit-sear), Patient Information Leaflet (PIL), Medical Product Evaluation (Pro-Eva), Periodic Safety Update Report (PSUR) and pivotal calculation of Patient Exposure (Pat-exp), Question and Answer Document (Q&A) and Request for Further Information (RFI), Scientific Advise (Query), Risk Management Plan (RMP), and Summary of Product Characteristics (SPC).
Senior Medical Manager Jan 2003 - Mar 2013
Managing and performing clinical and nonclinical research into investigative APIs and products of projects with emphasis on phase I to IV clinical development. Creating and execution of drug development plans (e.g., RR-glycopyrrolate, flupirtine). Deputizing the Head of Clinical Research since 2012.
Completely or partially planning conducting/managing, reporting of quality controlled or explorative studies (GLP, GCP, OECD) at CRO’s on bioanalytics & development, ADME, pharmacodynamics, safety pharmacology, acute/chronic/geno/eco TOX, clinical pharmacokinetics, bioequivalence, safety&efficacy (RCT), post marketing surveillance.
Education
University of Tübingen 1975 - 1984
Field of study: Medicine
Degree: M.D.
Skills
Arzneimittelentwicklung / Drug Development (R&D), Klinische Zulassungsdokumentation / Common Technical Documents (eCTD), Medizinische Wissenschaften (MedWiss) / Medical Affairs, Klinische Forschung (Klifo) / Clinical Research (R&D) , Klinische Pharmakologie / Clinical Pharmacology, Medizinische Informatik / Medical Informatics
Professional interests
Now I like to make use from more than 25 years of experience, knowledge and methodology in R&D and regulatory medical writing as a physician at the pharmaceutical industry.
I am looking for R&D related to epigenetics, immunology, microbiology and neurology with a PhD option. Here I expect challenging results on diseases like fibromyalgia, CFS and chronic arthritis.
CV
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Contact details
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