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Katrin Spiegel | Elance
 
176985602337900
Last Sign-in: Sep 29, 2014

Katrin Spiegel

Expert medical and regulatory writer
   France
Paris

Overview

I'm a passionate medical writer with 8 years of experience in the pharmaceutical industry both in pre-clinical and clinical development. I have written several CSRs and MAA/NDA's and I am proficient in writing systematic reviews and reports of clinical trials for publication according to current standard. Disease areas I'm familiar with include oncology, neurodegenerative, respiratory, and gastrointestinal diseases. I'm a careful listener, attentive to detail, a logic mind, and I'm enjoying working with a varied group of people.

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Skills (8)

Tested
Medical Transcription
My Score
avg
Passed
French - English Translation
My Score
avg
Passed
systematic reviews
Regulatory affairs
English-German Translation
Italian-English Translation
Academic Writing
My Score
avg
Passed

Service Description

I offer a diligent writing service for clinical documents, including CSRs, specific parts of MAA and NDA, and clinical study protocols.
I also offer consulting and writing service for query responses to agency inquiries/protocol objections and I am experienced in the writing of briefing documents in the context of scientific advice or special protocol assistance procedures.
I'm usually involving the relevant partners during the writing process (statisticians, medical director, project manager, pharmacovigilance) in order to assure a first quality control. However, once I have gathered the relevant information, I'm very independent and pragmatic in providing first-class documents, compliant with current guidelines.
In the past, I have written several CSRs, some of them being part of MAA and NDA submission. I have written parts of the non-clinical and clinical overview/summary of Module 2 of the CTD as well as responses to D120 and D180 questions.
I have written about 100 reply documents to agency inquiries regarding clinical study protocols.

I'm also offering writing service of systematic review and journal articles of clinical trials according to relevant guidelines (such as PRISMA and CASP checklist, Cochrane handbook, and specific journal requirements). I have acquired the experience and necessary skills during my Msc in international health technology assessment.

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Employment

AB Science
Medical writer/ regulatory affairs
2012 - 2014
Writing of clinical study reports, MAA and NDA submissions. Editing of clinical study protocols, Investigator Brochure, Informed Consent Forms. Writing of regulatory documents (briefing documents,...
Novartis
Investigator II
2006 - 2012
Using computational tools to enhance drug discovery process at different stages: -hit finding: analysis of HTS data and selection and characterization of hits; assembling screening libraries for...

Education

University of Sheffield
Master international health technology assessment
2013 - Present
University of Pennsylvania, USA
Postdoctoral fellow
2004 - 2006
International School of Advanced Studies, Trieste
PhD statistical and biological physics
2000 - 2004
Eidgenossische Technische Hochschule (ETH)
Diplomierter Chemiker
1995 - 2000
Overview  |  Job History  |  Resume/C.V.

Keywords

clinical study reports
CTD
clinical study protocols
regulatory writing
systematic reviews
epidemiology
health technology assessment
briefing documents
scientific advice documents
special protocol assistance
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katrins
Type
Individual
Member Since
September 2014
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Katrin Spiegel | Elance

Katrin Spiegel