Remote Senior Medical Writer - Clinical Documents Lead

Precision for Medicine; Madrid; A distancia; EUR 65.000 - 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. This role requires planning, writing, editing, and QC of documents like protocols, IBs, CSRs, and narratives with strict adherence to regulatory guidelines.

You will ensure alignment with ICH, FDA, GCP, and eCTD requirements, maintain the Precision MW Style Guide, and collaborate with sponsors, vendors, and internal teams to deliver on

Formación

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.

Responsabilidades

• Plan, write, edit, format, and QC clinical documents on time.
• Manage documents from template to final version with sponsors/vendors.
• Independently formulate key messages from study data.
• Author complex content using regulatory and clinical knowledge.
• Communicate clearly with internal and client teams.
• Contribute to MW processes, SOPs, templates, and work instructions.
• Perform literature-based research to support writing.

Conocimientos

Medical writing

Regulatory knowledge

Scientific writing

Quality control

Communication

Educación

BS degree or equivalent in a scientific or medical discipline

Herramientas

Microsoft Windows

Teams

Word

Excel

Adobe Acrobat

PowerPoint

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. This role requires planning, writing, editing, and QC of documents like protocols, IBs, CSRs, and narratives with strict adherence to regulatory guidelines.

You will ensure alignment with ICH, FDA, GCP, and eCTD requirements, maintain the Precision MW Style Guide, and collaborate with sponsors, vendors, and internal teams to deliver on