Lena Juliette DAHER

En résumé

Entreprises

• Sanofi - Medical Writer

  Paris 2014 - maintenant Global Medical Affairs and Consumer healthcare departments
  
  * Provide scientific and medical support to the Medical experts: monitor worldwide literature on
  
  International databases and internal databases/ analysis of publications and guidelines
  
  relevant to the products of the portfolio (OTC drugs, anti-inflammatory drugs, antibiotics,
  
  gastroenterology medications, vitamins and food supplements, cardiology drugs...)
  
  * Regulatory and medical writing: marketing authorization renewals/ registration and periodic
  
  benefit risk assessments: ``Addendum to clinical overview'' (ACO) and Clinical Expert
  
  Statements (CES), ``clinical overview'' (CTD Module 2.5), clinical summary (CTD Module2.7)
  
  periodic benefit risk evaluation reports (PBRER), summary of clinical pharmacology, pediatric
  
  clinical overviews (EU-article 45 pediatric regulation), answer letters to health authorities
  
  questions
  
  * Scientific writing for marketing purposes: scientific brochure, abstracts...
  
  * Coordination and collaboration with different clinicians/medical experts and interaction with
  
  regulatory/publishing departments
  
  * Management of the planning/ coordination of the medical writing activity
  
  * Deep knowledge of European and international regulations (EMEA, ICH)

• Lincoln - Medical Writer, Sanofi -Mandated by LINCOLN

  Boulogne-Billancourt 2014 - maintenant

• Nidcom - Chargé de missions: rédaction scientifique et médicale

  2013 - 2013

• Nidcom - Medical writer

  2013 - 2013 * Collaboration with scientific and medical writing agencies
  
  * Literature review/ publications analysis/ managing literature with Endnote
  
  * Writing of a non-clinical overview (CTD module 2.4) for marketing authorizations in Europe
  
  * Writing of a scientific article, in dermatology field, for submission to a peer-reviewed journal

• Aureus Sciences - Analyste scientifique des essais cliniques

  2011 - 2012

• Aureus Sciences - Scientific analyst

  2011 - 2012 * Provide the scientific support to develop a database for clinical trials for Immuno-
  
  Inflammatory diseases
  
  * Scientific data analysis: Literature monitoring/ Analysis of publications and synthesis of
  
  data/Use of bibliographic management software (reference manager/ endnote)
  
  * Information and Knowledge Management: Designing a database for clinical data; data entry
  
  in the database, defining entry rules, create medical dictionaries and glossaries...
  
  * Scientific writing: writing documents and deliverables for European scientific projects
  
  (Biointelligence)/ Designing and writing of scientific posters for international conferences
  
  * Collaboration with pharmaceutical industries/ meetings with experts/ attend national and
  
  international conferences
  
  * Provide support to the team on clinical research aspects and methodology/Training
  
  colleagues on the basic principles of clinical research

• Louis Mourier Hospital - CRA training

  2011 - 2011 (AP-HP) (Department of internal medicine)
  Clinical research associate Training, 3 months,
  * Phase III clinical studies in thromboembolic diseases: patient screening, randomization, CRF
  
  filling, responding to queries, patient's visits (planning, sampling kits, treatments...),
  
  archiving documentation, reporting adverse effects
  
  * contribution in writing clinical study reports/ Protocol amendments requests
  
  * Phase IV clinical studies : International database for thromboembolic diseases (RIETE)

• APHP-Hôpital Louis Mourier - Stage Recherche clinique

  2011 - 2011 De février à avril 2011: stage en recherche clinique. Screening de patients elligibles, planning des visites de patients, saisie de données dans les CRFS, gestion des documents de travail de l'essai clinique (fiche de compliance des patients, dossier d'adjudication..)

• Inserm - Chercheur contractuel

  PARIS 13 2009 - 2009 CDD 6 mois. Département hématologie, Institut Cochin.

• INSERM - Research engineer

  PARIS 13 2009 - 2009 * Obtaining knockout mouse lines / Cell Culture / phenotyping and cell sorting
  
  * Writing protocols and scientific documents and presentations
  
  * Use of technical illustration software (ImageJ, canvas...)

• Institut Pasteur- Université Pierre et Marie Curie - Biologiste Doctorant

  2003 - 2008 Potentiel vaccinal des protéines de la famille MSP3 de Plasmodium falciparum: évaluation de différentes constructions de MSP3-1, de quatre nouveaux membres de la famille de protéines MSP3, et d’une première construction multigénique

Formations

• Pierre Et Marie Curie University

  Paris 2010 - 2011 Clinical research degree (DIU- FIEC): Training of the Investigators for drug clinical trials.
  
  
  Course content : Clinical trials methodology and logistics, ICH regulations, clinical research
  protocol writing rules, CTD templates, writing of clinical study reports (ICHE3), critical reading of
  
  clinical trials publications, statistical principles of clinical trials (I

• Université Paris 6 Pierre Et Marie Curie UPMC

  Paris 2009 - 2010 Formation des investigateurs aux essais cliniques des médicaments
  
  DIU-FIEC

• Institut Pasteur

  Paris 2007 - 2014 Biostatistics training. (5 days) Sanofi trainings: (1) Bibliographic search Medline and Embase use; (2) Pharmacovigilance: (3)
  till now Domasys training; (4) Quosa bibliography tool

• PASTEUR INSTITUTE

  Paris 2004 - 2008 PhD
  
  * Animal Experimentation / Cell Culture / Immunology and Parasitology techniques (ELISA,
  Flow cytometry, Western blot, antibody purification...)
  * Literature monitoring ;
  * Synthesize, write and present data in scientific conferences in French and English
  * Writing scientific articles/ experimentation protocols
  * Management of scientific collaborations with the pharmaceut

• Pierre Et Marie Curie University

  Paris 2004 - 2008 Doctor of Philosophy

• Université Paris 6 Pierre Et Marie Curie UPMC

  Paris 2004 - 2008 Doctorant-allocataire de recherche
  
  Biologie génetique et Immunologie des infections parasitaires

• Université Paris 6 Pierre Et Marie Curie UPMC

  Paris 2003 - 2004

Réseau

• Bläsi Flerchinger MATHILDE

• Claire BORDE

• Daniel LEFORT

• Helene SABETAY

• Jean-Jacques DESCOMBES

• Jennifer AGUIAR

• Kenza BOUMEZBEUR

• Laurence-Stephanie-Aurelie LSA

• Nicolas BRUNELLE