Medical Writer
il y a 3 semaines
Prise de poste non définie BAC +3/+4 Paris
Nombre de postes non défini CDI À négocier
**Description du poste et des missions**:
**Poste**
Medical Writer
**Mission**
Le rédacteur médical sera un contributeur actif/auteur principal de la documentation réglementaire et scientifique, gérera la collecte globale de contenu auprès d'équipes fonctionnelles pour produire des documents conformes aux lignes directrices de l'entreprise et aux réglementations gouvernementales internationales, et gérera les livrables des rédacteurs des fournisseurs externes. Les exemples de documents comprennent, sans s'y limiter, les protocoles cliniques, les rapports d'études cliniques et non cliniques, les brochures destinées aux chercheurs et les sections cliniques et non cliniques des demandes de nouveaux médicaments expérimentaux et des demandes de mise sur le marché. Les documents réglementaires stratégiques tels que les réponses des agences et les dossiers d'information seront également rédigés/gérés. Le titulaire de ce poste sera responsable de la création de documents médicaux en anglais chez le laboratoire, en veillant à la qualité, à la rapidité et à l'efficacité de l'élaboration de documents cliniques et réglementaires conformes aux normes internes et externes.
Périmètre de consultation
- Institut de Recherches Internationales du laboratoire
- Biométrie
- Rédaction médicale en oncologie
Description du besoin
Le rédacteur médical veillera à ce que les documents cliniques et non cliniques (par exemple, les rapports d'étude, les protocoles d'étude, les résumés/aperçus, les brochures de l'investigateur, les documents de réponse de l'agence et d'autres documents de soumission réglementaire globale, le cas échéant) présentent de manière précise et cohérente les messages cliniques clés conformément aux objectifs du programme et aux exigences réglementaires, et à ce que la continuité et la cohérence des données cliniques soient maintenues depuis le concept jusqu'à l'octroi de licences et la divulgation.
Les activités (réalisées avec une supervision mínimale) comprendront, mais sans s'y limiter, l'édition, la rédaction, l'élaboration et le maintien de calendriers, la gestion de projets et la participation à des équipes de projet.
Servira de contact principal pour la rédaction médicale au sein des équipes d'étude.
Coordonnera les efforts des équipes interfonctionnelles pour produire des documents de haute qualité et scientifiquement exacts.
Veillera à ce que les produits livrables soient conformes à toutes les réglementations, normes et directives applicables, y compris les directives ICH.
Encadrera et gérera le travail des rédacteurs juniors si nécessaire.
Gérera le travail et les produits livrables des rédacteurs contractuels/fournisseurs, si nécessaire.
Se tient au courant des normes de l'industrie, des exigences réglementaires, des lignes directrices et des procédures opérationnelles normalisées du département. Travaillera de manière transversale pour mettre à jour les procédures ou les pratiques, si nécessaire, afin de rester en conformité avec la réglementation et d'améliorer la qualité et l'efficacité internes.
**Profil**
Au moins 2 ans en tant que rédacteur médical
**Un peu de Calypse**:
Pour soutenir la recherche et améliorer chaque jour le quotidien des patients, depuis 2015, Calypse identifie et accompagne les meilleurs talents afin de répondre aux besoins des professionnels de l’industrie pharmaceutique.
Au cœur de notre offre de service, vous, futurs consultants, êtes contractualisés en CDI chez Calypse, et faites l’objet d’une sélection exigeante par nos équipes RH. Dans le cadre de la parfaite exécution des missions qui vous sont confiées, vous disposez d’un manager Calypse référent, d’un suivi personnalisé et d’un programme de formation continue exigeant.
Réactivité, Qualité et Proximité sont les 3 piliers de notre offre de service 360° qui couvre l’ensemble des besoins de la chaîne de valeur : du Consulting à la CRO en passant par la Data Science. Nous proposons ainsi à nos clients vos compétences à forte valeur ajoutée, dans nos différents cœurs de métiers.
Et les avantages...? Voici ce que l'on vous offre:
- Une rémunération attractive, revalorisée annuellement
- Un accompagnement personnalisé
- Des tickets restaurants
- Le pass Navigo pris en charge à 100%
- Des formations Et bien d'autres
N’hésitez plus, rejoignez l’équipe Calypse
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