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Maria-Giovanna GUALAZZI

Levallois-Perret

En résumé

Mes compétences :
Project Management
Languages
Scientific research
Adobe Photoshop
Microsoft Office
International relations
Drug development
Molecular and cellular biology
Team work
Communication
Microsoft Excel
Microsoft PowerPoint
Clinical Research
Monitoring
Team and project coordination
Medical writing

Entreprises

  • Aixial - Trial Transparency Manager at Sanofi

    Levallois-Perret 2017 - maintenant
  • Umanis - Medical Writer at Sanofi

    Levallois-Perret 2015 - maintenant Provide clinical document support and advanced scientific writing expertise to the clinical team to generate high quality submission-ready documents, specifically for Developmental Safety Update Reports (DSUR) and Investigator Brochures (IBs). Ensure accurate and timely completion/delivery of documents and information for clinical submissions. Manage the document review process. Organize, lead and participate in project team meetings to provide input regarding deliverables, timelines, and processes.
  • Quintiles - Clinical Research Associate for Amgen

    Durham 2014 - 2015 Clinical Operations -Contracted Partner of Amgen - Phase I-IV Clinical Trials.
    Therapeutic area: Cardiovascular Disease, Multiple myeloma, Non-Hodgkins Lymphoma, Osteoporosis, Hyperparathyroidism, Chron’s disease, Psoriasis, Asthma.
  • INSERM - Post-doctoral associate

    PARIS 13 2012 - 2013 Project leader : activities planning, protocol optimization, realization of scientific experiences, data analysis and results redaction, transcription of relevant scientific results and drafting of conclusions, strategies to develop scientific concepts, preparing written and oral presentations for the sharing of results at internal and external meeting, maintaining relationship with doctors and differents actors of the biomedical research field.

    Research project: stem cells as model to study a rare genetic disease leading to defects in cardiac development and cardiac reparation.
  • CNR-ITB and I.R.C.S.S. Multimedica, Scientific and Techonology - Researcher (PhD Fellowship)at ITB-CNR and I.R.C.C.S Multimedica, Scientific and Technology

    2009 - 2012 Project leader : activities planning, protocol optimization, realization of scientific experiences, data analysis and results redaction, transcription of relevant scientific results and drafting of conclusions, strategies to develop scientific concepts, preparing written and oral presentations for the sharing of results at internal and external meeting. Supervision of trainees.

    Research project: the role of microRNAs in cardiovascular system as innovative therapeutical tools for curing cardiovascular diseases.
  • I.R.C.S.S. Multimedica, Scientific and Techonology - Researcher (CDD Multimedica) at ITB-CNR and I.R.C.C.S Multimedica, Scientific and Technology

    2008 - 2009 Junior project leader: study of the role of microRNAs in cardiac hypertrophy and possible therapeutical application in heart failure.
  • University of Lisbon - Junior researcher (Fellowship) at CPM-UBMBE Research Institute for Med and Pharma Sciences

    2006 - 2007 Junior project leader within an inter-laboratories international collaboration: study of the oxidant properties and the neurobiological effects of bilirubin.

Formations

  • For Drug Consulting

    Malakoff 2014 - 2014 Clinical Research Associate/Attaché de Recherche Clinique (mention "Très bien")

    French and international regulation (BPC-GCP-ICH). French regulatory environment (ANSM, CPP, CNIL, CNOM, CCTIRS). Review and document design (protocol, Investigator's Brochure, CRF, e-CRF, informed consent, therapeutic area, Investigator's Trial File). Contact with investigators and collaborators. Visits and reports (selection, monitoring, start-up and close-up).
  • University Of Pennsylvania

    Philadelphie 2013 - 2013 MOOC

    1. Branding
    Marketing Strategy and Brand Positioning
    Customer Decision Making and the Role of Brand
    Effective Brand Communications Strategies and Repositioning Strategies

    2. Customer Centricity
    The Limits of Product-Centric Thinking
    The Opportunities and Challenges of Customer Centricity
    How Can Customer Centricity Be Profitable?

    3. Go to Market Strategies
    Omni-Channel Strategy
  • University Of Milan (Milan)

    Milan 2009 - 2012 Doctor of Philosophy (Ph.D.)

    Molecular Medicine PhD (specialized in Genomics&Proteomics).
    Thesis: The role of microRNA-199 in cardiovascular pathophysiology: potential effects on neurohormonal systems.
  • University Of Bologna (Bologna)

    Bologna 2004 - 2007 Master degree, Pharmaceutical Biotechnology

    Graduated with honors, 110/110 cum laude
    Thesis: "Does bilirubin counteract the antioxidant and proxidant effects of H2O2 in neurons?"
  • University Of Bologna (Bologna)

    Bologna 2001 - 2004 Bachelor degree, Biotechnology

    Graduated with honors, 110/110 cum laude
    Thesis: Study of the role of viral glycoproteins in the penetration mechanism of Herpes Simpex Virus (HSV) by optical biosensor.

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