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Rédaction scientifique/ Medical writing

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Rédacteur médical/Medical writer/Chargé d'affaires réglementaires
Catégorie :

Rédaction scientifique/ Medical writing

Date de dernière mise à jour :

22 juin 2018

Lieu :

Région parisienne

CV :

More than 30 years of pharmaceutical experience as a medical translator, clinical reviewer, medical translation manager, including 15 yearling as a senior medical writer and medical writing coordinator in a variety of professional settings (either free-lancing, outsourcing, contracting or acting as in-house staff in major pharma and medical device companies or CROs) provides a proven track record of a significant preclinical & clinical expertise in the written production of scientific papers, protocols, e-CTD documentation, pharmacological, toxicological, biological and clinical study reports for registration submissions or publication purposes in France, Europe, the United States and Japan, meeting both tight deadlines and planned timelines. Interpersonal oral & written communication/interface skills enable successful document coordination and preparation to be made in all European languages for in-house departments and/or registration authorities. French mother tongue and proficient use of English (bilingual) and several European languages.

Hold an MSc. in Drug Science, specialising in clinical trials and drug development;
Also hold an advanced degree (DESS) in language engineering and scientific translation (Medicine);
Hold a CRA training module.

Remarques :

Also trained as a CRA; familiar with GCP ICH guidelines for phase-I to IV studies and epidemiological surveys. Regulatory Affairs specialist for drug and medical device development

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