Senior Medical Writer - Remote Clinical Documentation Lead

Pfm; 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 development of high-quality clinical study documents, plan writing, edit/format, and perform QC reviews in line with ICH, FDA, GCP and eCTD requirements.

The role focuses on producing submissions across development stages, collaborating with sponsors, external vendors, and internal teams with meticulous attention to detail and timely delivery in a remote-friendly, fast-paced environment.

Formación

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
• 5+ years of experience as a Sr. Medical Writer in the sponsor and/or CRO setting or 7+ years of experience as a Principal Medical Writer.
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency requirements (EudraCT, CT.gov), and eCTD requirements for all phases of development.
• Impeccable attention to detail and ability to complete writing assignments in a timely manner.
• Ability to work in a fast-paced environment with multiple high-priority projects with no instruction on routine work and minimal instruction on new assignments

Responsabilidades

• Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including protocols, IBs, ICF templates, DSURs, CSRs, CSR narratives.
• Ensure smooth document management from draft to final approved version in collaboration with Sponsor, vendors, and internal teams.
• Independently formulate key messages from clinical study data.
• Author complex content using detailed knowledge of processes.
• Communicate clearly in writing and verbally with internal and client teams.
• Contribute to development/maintenance of medical writing processes, SOPs, templates, and work instructions for key documents.
• Demonstrate excellent problem-solving skills and literature-based research to support writing activities.
• Perform other duties as assigned.

Conocimientos

Medical writing

Regulatory knowledge

Attention to detail

Educación

BS degree in scientific/medical discipline

MS/PhD preferred

Herramientas

Microsoft Word

PowerPoint

Excel

Adobe Acrobat

Teams

Descripción del empleo

Precision Medicine Group is seeking a Senior Medical Writer/Principal Medical Writer to lead development of high-quality clinical study documents, plan writing, edit/format, and perform QC reviews in line with ICH, FDA, GCP and eCTD requirements.

The role focuses on producing submissions across development stages, collaborating with sponsors, external vendors, and internal teams with meticulous attention to detail and timely delivery in a remote-friendly, fast-paced environment.