Remote Senior Medical Writer — Clinical Documents Lead

Precision Medicine Group; Warszawa; Remote; PLN 180,000 - 300,000; Full time

Job summary

Precision Medicine Group in Poland is seeking a Senior Medical Writer/Principal Medical Writer to lead the development of high-quality clinical study documents, plan, write, edit, format and perform QC in line with ICH, FDA, GCP and eCTD requirements. The role requires 5+ years as Sr MW or 7+ years as PMW, a scientific degree, and strong communication, with ability to work remotely in a fast-paced, cross-functional team environment.

Qualifications

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

Responsibilities

• Lead development of clinical study documents including protocols, IBs, CSRs with regulatory guidance.
• Plan, write, edit, format, and QC review documents from start to finish with internal teams and sponsors.
• Independently formulate key messages from clinical study data.
• Communicate clearly with internal and client teams.

Skills

Medical writing

Regulatory writing

Clinical documentation

Communication skills

Quality control / QC review

Education

BS degree in scientific/medical discipline

Advanced degree (MS/PhD) preferred

Tools

Microsoft Windows

Microsoft Teams

Microsoft Word

Microsoft Excel

Adobe Acrobat

PowerPoint

Job description

Precision Medicine Group in Poland is seeking a Senior Medical Writer/Principal Medical Writer to lead the development of high-quality clinical study documents, plan, write, edit, format and perform QC in line with ICH, FDA, GCP and eCTD requirements. The role requires 5+ years as Sr MW or 7+ years as PMW, a scientific degree, and strong communication, with ability to work remotely in a fast-paced, cross-functional team environment.