Medical Writer
il y a 3 semaines
Descriptif du poste
AIXIAL GROUP, CRO (Clinical Research Organization), spécialisée dans les sciences de la vie.
Nous travaillons avec des laboratoires pour fournir un support technique sur des projets cliniques de phases I à IV et après commercialisation.
Depuis 2014, nous faisons partie de la famille Alten. Nous développons nos activités en France, en Belgique, République Tchèque, Danemark, UK, US...avec encore des perspectives de s'étendre plus à l'international.
Aixial Group, intervient en outsouring, en insourcing, pour des laboratoires pharmaceutiques, cosmétiques, du medical device, biotechnologie, nutrition, vétérinaire,...sur des activités des opérations cliniques, des affaires réglementaires, qualité, biométrie, pharmacovigilance, HEOR...
Nous recherchons un Medical Writer H/F dont les principales missions seront les suivantes:
La coordination et la rédaction de documents cliniques : (brochure investigateur, formulaire de consentement, cahier d'observation et carnet patient et rapport clinique)
La validation de l'ensemble des documents produits pour les essais cliniques de votre portefeuille
La rédaction de protocoles d'études cliniques internationales
La traduction des rapports d'études cliniques et des publications scientifiques
- La gestion du contrôle qualité des documents cliniques selon les standards internationaux et des procédures internes.
Profil recherché
- De formation scientifique (PhD) ou médicale (Médecin, Pharmacien), et vous justifiez d'au moins 2 ans d'expérience dans la rédaction des documents de recherche clinique.
- Vous maîtrisez les réglementations ICH/GCP/BPC et autres impératifs réglementaires liés aux études cliniques.
- Doté(e) d'un véritable sens critique, et d'une bonne capacité rédactionnelle, vous avez pu exercer comme rédacteur médical dans divers aires thérapeutiques.
- Anglais courant obligatoire.
Compétences attendues
- LANGUESAucune langue attendue
SAVOIR-ÊTRE
Aucun savoir-être attendu
SAVOIR-FAIRE
Aucun savoir-faire attendu
Entreprise
- Aixial Group, CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten family. We are developing our activities in France, Belgium, Germany, Czech Republic, Denmark, UK, US...with even more prospects for expanding internationally. Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,... activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR.
- Autres offres de l'entreprise**Personne en charge du recrutement**
Btissem EL MILOUDI
- _Talent acquisition partner_
Salaire
A négocier
Prise de poste
01/08/2023
Expérience
Minimum 2 ans
Métier
Rédacteur
Statut du poste
Cadre du secteur privé
Zone de déplacement
Pas de déplacement
Secteur d’activité du poste
INGÉNIERIE, ÉTUDES TECHNIQUES
Télétravail
Partiel possible
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