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Medical Writer Scientist
Il y a 2 mois
Prise de poste : 22/04/2024 BAC +5 Paris
Nombre de postes non défini CDI De 50k à 60k euros
**Description du poste et des missions**:
Nous recherchons un **Medical Writer Scientist** qualifié et motivé pour rejoindre une équipe dynamique au sein d'une grande entreprise pharmaceutique. Vous jouerez un rôle essentiel dans le façonnement de l'avenir des soins de santé grâce à la création de documents réglementaires et scientifiques essentiels.
**Aperçu du rôle**: En tant que scientifique en rédaction médicale, vous dirigerez l'élaboration de documents réglementaires et scientifiques, en veillant au respect des directives de l'entreprise et des normes réglementaires internationales. Vos responsabilités incluront la gestion d'équipes pluridisciplinaires, la coordination des rédacteurs externes fournisseurs et garantir la livraison en temps voulu de documents de haute qualité. Les exemples de documents sur lesquels vous travaillerez incluent les protocoles cliniques, les rapports d'étude, les brochures des investigateurs et les soumissions réglementaires.
**Responsabilités principales**:
- Agir en tant qu'auteur principal pour les documents réglementaires et scientifiques.
- Assurer une présentation précise et cohérente des données cliniques conformément aux exigences réglementaires.
- Servir de principal interlocuteur en rédaction médicale au sein des équipes d'étude.
- Coordonner les équipes pluridisciplinaires pour produire des documents de haute qualité.
- Encadrer et superviser le travail des rédacteurs juniors.
- Maintenir une connaissance des normes de l'industrie et des exigences réglementaires.
**Compétences et qualifications**:
- Diplôme avancé dans un domaine scientifique pertinent de préférence.
- 2+ années d'expérience en rédaction médicale réglementaire.
- Solide expérience dans les méthodes statistiques pour les essais cliniques.
- Excellentes compétences en communication et organisationnelles.
- Maîtrise de MS Word et EndNote.
- Capacité à gérer plusieurs projets avec des priorités concurrentes.
**Qualifications souhaitées**:
- Expérience en rédaction non clinique et clinique pour les demandes de marketing.
- Expertise dans les résumés en langage simple et les activités liées à la divulgation publique.
**Informations supplémentaires**: Ce poste peut nécessiter des déplacements nationaux et internationaux.
