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Medical Writter
Il y a 2 mois
**SMART IMMUNE RECRUTE UN(E) MEDICAL/SCIENTIFIC WRITTER H/F EN CDI**
SMART IMMUNE est une société de biotechnologie au stade recherche clinique qui développe les thérapies cellulaires issues de progéniteurs de lymphocytes T à travers une plateforme innovante appelée ProTcell. Ces thérapies cellulaires, nouvelle génération, permettent en un temps record le « reset » d’un système immunitaire capable de lutter efficacement contre les cancers et les infections, améliorant significativement le pronostic et la qualité de vie des patients.
Afin d’accompagner notre croissance, nous recherchons un(e) medical/scientific writter.
**Missions**:
Le medical/scientific writter participe à l'élaboration de documents cliniques et médicaux, de documents scientifiques, de documents analytiques et de documents réglementaires de haute qualité, en préparant et coordonnant l'élaboration de ces documents ou en contribuant à des documents élaborés par d'autres, par une contribution active. Il participle à l’élaboration des design d’études biostatistiques scientifiques et cliniques.
Il/elle aura pour missions, notamment de:
- Rédiger, réviser et éditer divers documents cliniques et/ou médicaux pour la soumission et/ou l'approbation de produits pharmaceutiques et en soutien à d'autres départements de SMART IMMUNE, y compris la recherche et le développement, les affaires réglementaires, la pharmacovigilance et la gestion des programmes (par exemple, les protocoles d'études cliniques, les Brochures, DSUR, aperçu clinique, plan d'investigation, rapports de sécurité clinique, documents d'information pour les autorités de réglementation et les comités consultatifs );
- Superviser les cycles d'examen des documents, notamment en incorporant les commentaires de l'équipe et en menant des discussions sur la révision et la finalisation des documents ;
- Participer au design statistique des études scientifiques et clinique
- Diriger l'élaboration et la maintenance de modèles et de procédures opérationnelles normalisées liées à la rédaction scientifique ;
- Examiner les documents édités par d'autres départements, y compris les ICF, les manuels de manipulation des produits.
- Assurer un suivi de la littérature pertinente en utilisant différentes sources ;
- Agir en tant que point de contact quotidien pour les autres départements pour toutes les activités de rédaction scientifique et médicale en assistant aux groupes de travail cliniques, fournir des échéanciers à respecter avec le groupe de travail clinique mondial ou les échéanciers réglementaires, et coordonner le développement de tous les documents.
- Identifier, communiquer et résoudre les problèmes ayant une incidence sur les échéanciers des documents ;
- Créer des documents précis, compréhensibles et adaptés au public visé ;
- Respecter les directives écrites et réglementaires acceptées et normalisées et des directives internes.
**Profil**
Formation souhaitée : Doctorat en sciences de la vie, en sciences biologiques ou dans un domaine connexe.
Expérience souhaitée : 5 ans d’expériences dans une société pharmaceutique (sponsor et/ou CRO).
Sont de plus
- Une expérience avec les documents réglementaires de l'UE et des États-Unis
- Une expérience en immunology et oncology est un plus
- Maitrise des biostatistiques, plans d’expérience (DoE).
Anglais écrit et oral est essentiel
**Aptitudes & Compétences**
- Rigoureux dans l'utilisation et le référencement des données ;
- Flexibilité et sensibilité aux délais de livraison serrés et difficiles;
- Solides compétences organisationnelles et de gestion du temps;
- Capacité à gérer les priorités.
Type d'emploi : Temps plein, CDI
Statut : Cadre
Avantages:
- Titre-restaurant
Programmation:
- Du lundi au vendredi
- Travail en journée
Types de primes et de gratifications:
- Heures supplémentaires majorées
Formation:
- Bac +5 (Master / MBA) (Optionnel)
Expérience:
- production cellulaire classique: 5 ans (Optionnel)
Lieu du poste : En présentiel
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