Medical Writer - Medical Affairs
Since July 2014
Writing of manuscripts Literature reviews Participation in executive committee meetings and collaboration with key opinion leaders Therapeutic areas: Cardiology, diabetology and oncology
June 2012 --- June 2014
Writing of the following documents: - clinical study reports, clinical protocols and investigator brochure in accordance with ICH guidelines
- literature review (clinical evaluation report) in accordance with MEDDEV guidelines - abstracts, posters and paper in collaboration with client and in accordance with conference/journal guidelines
- medical French-English translation, and editing of protocols
• Management of resources and project planning
• Collaboration with clients, biostatisticians, data managers, project leaders and clinical research associates
• Adverse Event coding using MedDRA and medical treatment coding using WHO Drug Dictionary software
Therapeutic areas: Parkinson disease, stem cell therapy (cardiology), Alzheimer’s disease, HIV, solid organ transplantation, ondontology along with medical devices pertaining to ENT.
Clinical Research Associate (CRA)
July 2010 --- January 2011
Performed monitoring visits (including SIVs and SCOVs) and prepared monitoring reports. Translated study protocols, essential documents, participated in international teleconferences and contacted ethics committee regarding amendments.
September 2008 --- June 2010
Gave English lessons to employees from large companies (groups and individuals).
senior research associate
June 2003 --- September 2008
Developed and patented a novel method to detect blood grouping antibodies and pathologies. Designed and implemented a feasibility study in order to develop a high through-put diagnostic assay (microarray). Published peer reviewed papers and patent. Presented (seminars and posters) at national and international conferences. Prepared protocols, PPT presentations and user guidelines for research team (microarray robot, scanner and imaging software).
August 2002 --- May 2003
Checked and verified that pharmaceutical analyses were correctly documented and were carried-out in compliance with SOPs and GLP. Conducted internal audits.
September 1997 --- September 1998
Screened pharmaceutical products for microbial contamination in compliance with FDA regulations and GMP. Prepared SOPs and investigation reports concerning sources of product contamination during manufacture.
Certificate in Clinical Research from SupSanté in 2010
PhD in science from The University of Edinburgh in 2002