Remote Senior Medical Writer: Clinical Documents Lead

Precision for Medicine; España; A distancia; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work options

Descripción de la vacante

Precision Medicine Group is seeking a Senior Medical Writer/Principal Medical Writer for a remote role based in Spain. The candidate will lead development of clinical study documents, coordinate with sponsors and vendors, and ensure compliance with ICH, FDA, GCP and eCTD requirements.

Experience includes planning, writing and editing protocols, CSRs, IBs, DSURs, and related documents with meticulous attention to detail. Advanced degrees preferred; oncology/rare disease experience is a plus.

Formación

• BS degree or equivalent in a scientific or medical discipline with writing expertise.
• 5+ years as a Sr. Medical Writer or 7+ years as Principal Medical Writer.
• Proficiency with MS Word, Excel, PowerPoint, Adobe Acrobat and Teams.
• Clear understanding of ICH, FDA, GCP and eCTD requirements across all development phases.
• Impeccable attention to detail and ability to manage multiple high-priority projects.

Responsabilidades

• Plan, write, edit, format, and QC high-quality clinical documents timely.
• Ensure document management from template to final version with sponsors/vendors.
• Independently formulate key messages from clinical study data.
• Author complex content with knowledge of processes and regulatory needs.
• Communicate clearly with internal and client teams in writing and verbally.
• Contribute to development of MW processes, SOPs, templates and work instructions.
• Perform literature-based research to support writing activities.

Conocimientos

Medical writing

Regulatory writing

Attention to detail

Communication skills

Literature research

Educación

BS degree or equivalent in a scientific or medical discipline

MS/PhD preferred

Herramientas

MS Word

MS Excel

Adobe Acrobat

PowerPoint

Microsoft Teams

Windows OS

Descripción del empleo

Precision Medicine Group is seeking a Senior Medical Writer/Principal Medical Writer for a remote role based in Spain. The candidate will lead development of clinical study documents, coordinate with sponsors and vendors, and ensure compliance with ICH, FDA, GCP and eCTD requirements.

Experience includes planning, writing and editing protocols, CSRs, IBs, DSURs, and related documents with meticulous attention to detail. Advanced degrees preferred; oncology/rare disease experience is a plus.