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Head of Regulatory / Medical WritingRef: BBBH23135

Salary:£80000 - £100000 per annum + bonus and benefits

Added:12 Jun 2018

Region: France

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

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

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