Freelance Medical Writer
Schlagwörter
Skills
In my >13 years of medical writing in small and big Pharma I have gained expertise
- in the preparation of
- regulatory and clinical documents (e.g. clinical study reports and protocols, briefing documents, investigator brochures, clinical summary documents) and
- medical communication materials (e.g., manuscripts, abstracts, oral and poster presentations)
- early clinical development (including first-in-human)
- vaccines, biosimilars, and diverse therapeutic areas (e.g., infectious diseases, oncology, neurodegenerative diseases)
- working efficiently with cross-functional project teams
Projekthistorie
06/2020
-
bis jetzt
04/2019
-
05/2020
Associate Director Global Regulatory Medical Writing
Pharmacology projects
Associate Director Global Regulatory Medical Writing * Mentored, trained, and coordinated
internal and external Medical Writers
Associate Director Global Regulatory Medical Writing * Mentored, trained, and coordinated
internal and external Medical Writers
04/2011
-
04/2016
Sr Principal Medical Writer
Janssen Vaccines (J&J company; formerly: Crucell Switzerland)
* Wrote or led the writing of clinical, regulatory, and safety documents both for early phase and
marketed products (infectious diseases)
* Registered clinical studies and posted results at public databases (clinicaltrials.gov)
marketed products (infectious diseases)
* Registered clinical studies and posted results at public databases (clinicaltrials.gov)
01/2009
-
03/2011
Medical Writer
Antisense Pharma
* Coordinated all in/external writing activities
* Wrote peer-reviewed manuscripts and oral & poster presentations for major oncology congresses
(ASCO, AACR)
* Assembled a Hot Topic Issue on TGF-β as target in oncology in Current Pharmaceutical
Biotechnology: https://benthamscience.com/journals/current-pharmaceutical-biotechnology/volume/12/issue/12/
* Wrote peer-reviewed manuscripts and oral & poster presentations for major oncology congresses
(ASCO, AACR)
* Assembled a Hot Topic Issue on TGF-β as target in oncology in Current Pharmaceutical
Biotechnology: https://benthamscience.com/journals/current-pharmaceutical-biotechnology/volume/12/issue/12/
01/2007
-
12/2008
Medical Writer
IFE Europe
* Wrote clinical and scientific documents in various therapeutic areas (mainly GI and CNS
diseases)
* Set up and managed a clinical study (monocentre, 200 pts)
* Involved in set up of advisory boards and development of a new assessment scale for Alzheimer`s
diseases)
* Set up and managed a clinical study (monocentre, 200 pts)
* Involved in set up of advisory boards and development of a new assessment scale for Alzheimer`s
08/2000
-
12/2006
Research Scientist
Reisebereitschaft
Verfügbar in den Ländern
Deutschland