Expert Assurance Qualité Documentation (H/F)

Temps complet | Montpellier, LANGUEDOC ROUSSILLON | environ 2 mois

Résumé de l'emploi

Temps complet

Description de poste

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

The Senior Medical Writer is a member of the Clinical Team. 

  • He/she is responsible for the production of key documents related to Clinical Department and Medical Affairs activities (e.g., protocol, CSR, IB/CTA, CTD clinical modules within required timeline.
  • He/she will work in collaboration with internal clinical teams and representatives from other functions, in line with Company as well as external standards, e.g., regulatory guidelines.

 The Senior Medical Writer will also ensure oversight of clinical documents prepared by external vendors

Role and responsibilities:

The Senior Medical Writer:

  • Is in charge of coordinating the preparation of protocols, IBs/CTAs and clinical study reports according to Sanofi document standards, tools, and SOPs
  • Is in charge coordinating the preparation of CTD clinical summaries in line with Sanofi document standards
  • He/she is coordinating the clinical documentation CTD activities (e.g. key contact with regulatory and other functions involved)
  • Leads on Process or Template improvement initiatives as requested.
  • Is in charge of supervising subcontracted medical writing activities.

Education and Qualifications:

  • BA/BS in Biology, Life Sciences and 3 plus years of medical writing experience;
  • Masters in Science degree, PharmD or PhD in Science is preferred
  • Excellent oral and written English skills
  • Demonstrated experience in clinical development, strong interpersonal, time management, project management, and technical writing skills highly desirable.

Sanofi s’engage en faveur de l'accueil et de l'intégration des personnes en situation de handicap.

Sanofi is committed to welcoming and integrating people with disabilities

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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