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Experiences

Current Experience

  • 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

Past Experience

  • Medical Writer
    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

    Other activities:

    • 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.

  • English Teacher
    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).

  • Pharmaceutical Analyst
    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.

  • Microbiologist
    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.

Knowledge

LinkedIn Assessment :
CROClinical trialsICH-GCPGCPClinical monitoringPharmaceutical IndustryMedical writingClinical DevelopmentClinical researchLife SciencesProtocolPharmaceuticsSOPTherapeutic AreasBiotechnologyMedical DevicesCardiologyGLPGMPoncology

Education

  • Certificate in Clinical Research from SupSanté in 2010
  • PhD in science from The University of Edinburgh in 2002

Languages

BrightOwl Assessment:
Self Assessment:
French
Full Proficiency
English
Native

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Senior Medical Writer
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    France
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

78300 Poissy, France

Others

Driving License
  • Yes