Rédaction scientifique/ Medical writing
31 mars 2011
Ile de France
PERSONNAL & PROFESSIONAL PROFILE
A dedicated and self motivated professional, highly educated with regulatory and clinical trial knowledge and experience in medical writing. Possesses excellent interpersonal and communication, as well as the capacity for autonomous learning and adaption to new situations.
My objective is to continue to make the best use of my existing skills and experience whilst enabling further personal and professional development in regulatory affairs.
PROFESSIONAL EXPERIENCE
Medical writer - Biotechnology society June 2010 - Present
Responsible for the writing of the study documents from the protocol to the Clinical Study Reports in the oncology and inflammatory disease fields
• Medical writing activities for preparing and submit protocols to AFSSAPS and Ethics Committee for clinical trials on medicinal products, and responses to health authorities questions
• Lead the writing of clinical study reports in collaboration with the statisticians and the pharmacovigilance department
• Write protocols, inform consents and study documentation (ex : phase 2 in multiple myeloma, phase 3 in rheumatoid arthritis………)
• Redaction narratives for Serious Adverse Events as required, to incorporate in clinical study reports
Medical writer - LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES
January 2009 - June 2010
Experience working on CTD regulatory documents, especially in pediatrics, in the fields of immunology and homeostasis.
• Wrote Pediatric Investigation Plans for new medicine according to European regulation
• Managed an external provider responsible for performing a meta-analysis
• Wrote the publication which was part of the regulatory authorities submission file
• Provided input in marketing application in extended indication , by creating the module 2 of the CTD documents (clinical overview and Summary of Clinical efficacy)
Clinical Research Associate/medical writer - ADVANCED DRUG DEVELOPMENT SERVICES
Jan 2008 – Dec 2008
Involved in the whole clinical study process, from protocol preparation to clinical trial monitoring, in a broad range of research fields.
• Provided input in writing documents (epidemiology reports, protocols)
• Ensure the monitoring of phase III clinical trials in oncology, neurology and neuropsychology, ensure compliance with GCP, SOPs and local regulatory requirements (visiting study centers on a regular basis i.e. 3 visits a week on two phase 3 studies, training site staff to industry standards, locating and assessing the suitability of facilities at a study centre, source data/document verification, collecting completed CRFs, writing visit reports, ensuring all unused trial supplies are accounted for, archiving study documentation and correspondence)
• Contributed to the study feasibility assessment in France
Doctoral Researcher - IPSEN-BEAUFOUR/CNRS UMR 7091
Jan 2003- Dec 2008
Developed experimental and functional analysis methods to allow the use of microarray technology, in collaboration with Beaufour Ipsen company.
Research Subject : sarcopenia and the effect of a Ginkgo Biloba extract on striated muscle gene expression:
• Attend laboratory course on microarray-based genomic tests (All, Frigbourg)
• Contributed to the development of a new microarray platform in the laboratory, and publication of a paper using microarrays data
• Trained and provided support to the researchers using microarrays
• Optimization of high-density cDNA-microarray protocols by design of experiments
• Attended congresses (Society for Neuroscience , Avignon 2003; International Congress of Myology, Nantes 2005)
• Oral presentation of microarrays use (methods, fields, benefits and drawbacks) for CNRS researchers (required by Amersham company)
• Performed electrophysiology experiments in collaboration with CNRS UPR 9040 (Directed by Dr Jordi Molgó)
EDUCATION AND TRAININGS
2009-2010 Master of Regulatory Affairs in Health Industries
Paris-sud 11 university
2008 Clinical Research Associate certificate
Advanced Drug Development Services "ADDS"
2004 One year University Degree (DIU) - Myology
Pierre et Marie Curie (Paris 6) University
2003-2008 PhD. Molecular Genetics and Physiology
"Laboratoire de Génétique Moléculaire de la Neurotransmission et des processus
neurodégénératifs" CNRS UMR 7091 (Paris 13ème)
Paris Descartes University, doctorate funded by Beaufour IPSEN society (CIFRE)
2002 Master of Advanced Studies (DESS) - Bioinformatics
Paris 7 – Denis Diderot University
1998-2001 Four years university degree in biochemistry in specialties:
- Immunology
- Pharmacology
- Economy
Paris 7 – Denis Diderot University
ADDITIONAL INFORMATION
Languages: Scientific English (writing + oral), Spanish (basic)
Computer literate: Microsoft office (Word, Excel, PowerPoint), Adobe Photoshop, EndNote, statistics software "ORIGIN"
Full clean driving license
PUBLICATION
Bidon C, Lachuer J, Molgó J, et al: The extract of Ginkgo biloba EGb 761 reactivates a juvenile profile in the skeletal muscle of sarcopenic rats by transcriptional reprogramming. PLoS One. 2009 Nov 24;4(11):e7998.
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