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Job summary
A biotechnology company in Paris is seeking a skilled medical writer to prepare regulatory and clinical study documentation, including marketing authorization applications. Ideal candidates will have a post-graduate degree in a biomedical field and experience in scientific writing. This role requires fluency in English and the ability to manage multiple projects under tight deadlines.
Qualifications
Post-graduate science degree in a biomedical field.
Previous medical or scientific writing experience.
Advanced scientific writing skills.
Responsibilities
Medical writing of regulatory and clinical study documentation.
Preparation of regulatory responses to health authorities.
Manage several projects and meet tight deadlines.
Skills
Medical writing
Analytical skills
Scientific writing
Regulatory submissions
Fluency in English
Education
Post-graduate science degree
Job description
Responsibilities
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
Qualifications
Male or female with Post-graduate science degree in a biomedical field
Previous medical or scientific writing experience
Ability to analyse and summarise data from a diverse range of indications
Advanced scientific writing skills
Experience in the preparation of marketing authorisation applications and regulatory responses would be advantageous
Fluency in written and spoken English
Based in Paris
Salary & package to define according skills and experience