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
-
Medical Writer
il y a 5 jours
Paris, France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Medical Writer
il y a 4 jours
Paris, France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Medical Writer
il y a 5 jours
Paris, Ile-de-France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Medical Writer
il y a 5 jours
Paris, France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Medical Writer
il y a 5 jours
Paris, France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Freelance Medical Writer
il y a 6 jours
Paris, France Klick Temps pleinFreelance Medical Writer Paris, FranceFreelance – Medical Freelancers /Freelance /Hybrid Job Description We’re looking for a confident and experienced Freelance Medical Writer to join our rapidly growing team. The successful candidate will have the opportunity to work on a range of projects across the full spectrum of medical communications...
-
Freelance Medical Writer
Il y a 3 mois
Paris, France Klick Health Temps plein**Please submit your resume in English** **Scientific Knowledge and Skills**: - Combines a thorough understanding of the therapeutic area with product strategy to ensure communication objectives are met on assigned projects. - Is able to identify and leverage relevant, focused resources to understand the underlying science and product strategy related to...
-
Freelance Medical Writer
il y a 5 jours
Paris, France Klick Health Temps plein**Please submit your resume in English** **Scientific Knowledge and Skills**: - Combines a thorough understanding of the therapeutic area with product strategy to ensure communication objectives are met on assigned projects. - Is able to identify and leverage relevant, focused resources to understand the underlying science and product strategy related to...
-
Freelance Medical Writer
il y a 4 jours
Paris, France Klick Temps pleinWe’re looking for a confident and experienced Freelance Medical Writer to join our rapidly growing team. The successful candidate will have the opportunity to work on a range of projects across the full spectrum of medical communications activities, including traditional and digital deliverables. To be successful in your application, you have solid...
-
Freelance Medical Writer
il y a 4 jours
Paris, France Klick Temps pleinJob DescriptionWe’re looking for a confident and experienced Freelance Medical Writer to join our rapidly growing team. The successful candidate will have the opportunity to work on a range of projects across the full spectrum of medical communications activities, including traditional and digital deliverables. To be successful in your application, you...
-
Senior Medical Writer
il y a 5 jours
Paris, France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Senior Medical Writer
il y a 5 jours
Paris, France Ividata Life Sciences Temps pleinThe Senior level Medical Writer will be responsible for the creation of English-language medical writing deliverables ,ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2)...
-
Medical Writer
il y a 2 semaines
Paris, France Calypse Temps pleinPrise 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...
-
Medical Writer
Il y a 3 mois
Paris, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Medical Writer LRPPV 314
il y a 2 jours
Paris, Ile-de-France ProductLife Group Temps pleinProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub:ResponsibilitiesActing as LRPPV in France and as single point of contact to French health authoritiesAnswers to questions from authorities (national, European surveys, ad hoc answers) requiring medical...
-
Medical Writer LRPPV 314
il y a 2 jours
Paris, France ProductLife Group Temps pleinProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub:ResponsibilitiesActing as LRPPV in France and as single point of contact to French health authoritiesAnswers to questions from authorities (national, European surveys, ad hoc answers) requiring medical...
-
Medical Writer LRPPV 314
il y a 2 jours
Paris, France ProductLife Group Temps pleinProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub: Responsibilities Acting as LRPPV in France and as single point of contact to French health authorities Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical...
-
Medical Writer LRPPV 314
il y a 3 jours
Paris, France ProductLife Group Temps pleinProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub:ResponsibilitiesActing as LRPPV in France and as single point of contact to French health authoritiesAnswers to questions from authorities (national, European surveys, ad hoc answers) requiring medical...
-
Medical Writer LRPPV 314
il y a 3 jours
Paris, France ProductLife Group Temps pleinProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub: Responsibilities Acting as LRPPV in France and as single point of contact to French health authorities Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical...
-
English-writer
il y a 2 jours
Paris, France ProductLife Group Temps pleinProductLife Group is looking for a Medical Writer and LRPPV France to join our dynamic team to contribute to the activities performed in the Hub: Acting as LRPPV in France and as single point of contact to French health authorities Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis Represents...
