Description
An excellent opportunity has arisen for a Head of Regulatory / Medical Writing to join a Paris based pharmaceutical company specialising in the discovery, development, and commercialisation of novel targeted therapies for treating cancer, chronic inflammatory diseases and neurological degenerative disorders.
Within this role your will work with a highly diverse range of projects including preparation of all types of regulatory and clinical study documentation as well as 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 (eCTD module 2)
Simultaneously manage several projects and meet tight deadlines
Profile:
Previous medical or scientific writing experience
Ability to analyse and summarise data from a diverse range of indications
Advanced scientific writing skills
Post-graduate science degree in a biomedical field
Experience in the preparation of marketing authorisation applications and regulatory responses would be advantageous
Fluency in written and spoken English
For further information about this role, or other vacancies within regulatory, please contact Tim Barratt on +44(0)1727 817 626 or email your CV to tbarratt@keypeople.co.uk
