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Référence: GHL081002
Date de publication: 08/10/2025
Offre consultée 247 fois
Senior scientific and regulatory writer / Rédacteur scientifique et réglementaire senior H/F
Secteur : Biotechnologies Famille de fonction : Développement clinique
Prise de poste : 01/12/2025
BAC +5
Paris
Nombre de poste : 1
CDI
À négocier
gilleslaurent@ghlconsult.com
Description du poste et des missions
Laboratoire conduisant des études cliniques en France et à l'international recherche un Senior scientific and regulatory writer H/F.
Main responsibilities will be to participate in the preparation of registration dossiers, responses to health authorities and other clinical study documentation.
Responsibilities include:
- Medical writing of all types of regulatory and clinical study documentation including Investigators’ Brochures, clinical study reports and protocols
- Preparation of regulatory responses to health authorities
- Preparation of marketing authorisation applications
- Simultaneously manage several projects and meet tight deadlines
Profil souhaité
Profile:
- Ability to analyse and summarise data from a diverse range of indications
- Advanced scientific writing skills
- Post-graduate science degree in a biomedical field
- Fluency in written and spoken English
Compétences requises
Previous medical or scientific writing experience (at least 5 years)
Experience in the preparation of marketing authorisation applications and regulatory responses would be advantageous
Informations du recruteur
Nom et prénom
laurent gilles
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