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Séverine LehouxSL

Séverine Lehoux

Clinical Project Manager/Medical Writer

€600/day
Paris, FR
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Séverine

As an international clinical project manager, I have acquired significant management skills over 8 years in multiple therapeutic areas such as oncology, multiple sclerosis, and respiratory diseases (asthma). I have also gained significant skills in managing CROs and international suppliers with complete budget and tender supervision. I also acquired expertise in preclinical development (in vitro and in vivo) as an R&D project manager in a pharmaceutical industry in Australia. With my 15 years of professional experience in public (French and American) and private (French and Australian) research, I have also developed expertise in in vitro and in vivo analyses with in-depth knowledge of diabetes, particularly type 2 diabetes.
Recently, I embarked on a new challenge as a medical writer. My three years of experience have so far led me to prepare and write patient safety documents (narratives) as well as prepare and monitor the complete project budget for the sponsor. For this new medical writing challenge, which is not entirely new to me given my experience in public research (writing articles, publishing a book, and writing protocols), I am currently undergoing certification in regulatory medical writing (Formatis and Stanford University).
  • French

    Native or bilingual

  • English

    Fluent

Remote only
Primarily works remotely

Experience

  • INSTITUTdesMICI
    Medical Writer
    November 2024 - November 2024 (1 month)
    -Review and writing of all SOPS for clinical department (regulatory, quality)
    -Creation of new SOPs


  • CRO Excelya-Medical
    Writer Coordinator
    July 2021 - September 2024 (3 years and 2 months)
    -Narratives vendor coordinator/Medical writer coordinator for SANOFI-International trials ∗ Project management with CROs international ∗ Vendors oversight (budget, meeting): TCS, Cognizant ∗ Medical writer coordinator: narrative template, narrative writing quality check, study's timelines ∗ Review of narratives document: vendor's quality check of writing versus source documents
    ∗ Review of SOP for medical writing
  • CRO Excelya-Clinical
    Project Manager
    July 2018 - July 2021 (3 years)
    -Global study manager for SANOFI-International trial in Rare Disease-Pediatric Multiple Sclerosis ∗ Project management with CROs international ∗ Vendors oversight: Covance, Neurostatus, Esms, PPD ∗ Data management oversight (eCRF cleaning, Data Base Lock oversight) ∗ Patients profiles-Medical Review

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Education

  • Clinical Research Project Manager training
    FORMATIS
    2016
    Clinical Research Project Manager training
  • DU Experimentation
    UNIVERSITY
    2009
    DU Experimentation

Skill set

Categories

  • Other