Remote Senior Medical Writer: Clinical Study Documents Lead

Precision Medicine Group; España; A distancia; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is seeking a Senior Medical Writer/Principal Medical Writer to lead the development of high-quality clinical study documents in Spain. You will plan, write, edit, format, and QC protocols, IBs, CSRs and associated narratives with regulatory-compliant content and eCTD readiness.

The role requires 5+ years as a Senior Medical Writer or 7+ years as a Principal Writer, strong regulatory knowledge (ICH, FDA, GCP) and solid MS Office skills. Advanced degree preferred.

Formación

• BS degree or equivalent in science/medicine.
• 5+ years as Sr. Medical Writer or 7+ years as Principal Medical Writer.
• Experience in sponsor/CRO settings.
• Strong regulatory writing knowledge (ICH, FDA, GCP).

Responsabilidades

• Lead planning, writing, editing, formatting, and QC of clinical documents.
• Develop documents per ICH, FDA, GCP and eCTD requirements.
• Collaborate with Sponsor, vendors and project teams.
• Independently formulate key messages from study data.
• Maintain writing processes, SOPs, templates and work instructions.
• Literature-based research to support writing.

Conocimientos

Regulatory writing

Clinical writing

Editorial QC

Content planning

Communication

Educación

BS degree in science/medicine

MS/PhD (preferred)

Herramientas

MS Word

PowerPoint

Excel

Adobe Acrobat

Teams

Descripción del empleo

Precision Medicine Group is seeking a Senior Medical Writer/Principal Medical Writer to lead the development of high-quality clinical study documents in Spain. You will plan, write, edit, format, and QC protocols, IBs, CSRs and associated narratives with regulatory-compliant content and eCTD readiness.

The role requires 5+ years as a Senior Medical Writer or 7+ years as a Principal Writer, strong regulatory knowledge (ICH, FDA, GCP) and solid MS Office skills. Advanced degree preferred.