Freelance Medical Writer

iO Associates; Münchendorf; Hybrid; EUR 40 000 - 60 000; Teilzeit

Zusammenfassung

A recruitment agency is looking for a freelance Medical Writer in oncology to draft Clinical Study Reports. The role requires 3+ years of medical writing experience and fluency in English and German. Responsibilities include ensuring regulatory compliance and collaboration with clinical teams. A hybrid work model is offered with occasional on-site requirements in Munich.

Qualifikationen

• Minimum 3 years of experience in clinical or regulatory medical writing.
• Strong understanding of oncology clinical trials and CSR structure.
• Familiarity with EMA submission processes and ICH guidelines.

Aufgaben

• Draft and revise the Clinical Study Report (CSR) based on clinical data.
• Ensure alignment with ICH E3 and EU regulatory standards.
• Prepare final, submission-ready documentation.

Kenntnisse

Medical writing

Collaboration with teams

English fluency

German fluency

Oncology research knowledge

Tools

EndNote

Zotero

Jobbeschreibung

Freelance Medical Writer (Oncology - CSR)

Location: Hybrid with 1 day per month on-site (EU-based candidates only)
Client Location: Munich, Germany
Contract Type: Freelance / Part-Time
Duration: 4 months
Start Date: 1st August 2025
Language Requirements: Fluent in English and German
Weekly Commitment: Approx. 20 hours/week

About the Client

Our client is a mid-sized pharmaceutical company headquartered in Munich, focused on advancing oncology therapies through innovative clinical research. With a strong pipeline and a collaborative culture, they are seeking a freelance medical writer to support the development of a Clinical Study Report (CSR) for a recently completed Phase II oncology trial.

Role Overview

As a freelance medical writer, you will be responsible for drafting and finalising a CSR in accordance with ICH E3 guidelines. You will collaborate with internal clinical and regulatory teams to ensure the document is scientifically accurate, regulatory-compliant, and submission-ready for the European Medicines Agency.

Key Responsibilities

• Draft and revise the Clinical Study Report (CSR) based on clinical data and statistical outputs
• Ensure alignment with ICH E3 and EU regulatory standards
• Collaborate with cross-functional teams for input and feedback
• Incorporate revisions from clinical, regulatory, and quality teams
• Prepare final, submission-ready documentation

Required Qualifications

• Minimum 3 years of experience in clinical or regulatory medical writing
• Strong understanding of oncology clinical trials and CSR structure
• Fluent in both English and German (written and spoken)
• Based in the Germany
• Familiarity with EMA submission processes and ICH guidelines

Preferred Skills

• Experience with Phase II oncology studies
• Proficiency with referencing tools (e.g., EndNote, Zotero)
• Prior experience working with German or EU-based pharmaceutical clients

If you're interested in contributing to a dynamic and growing pharmaceutical business at the forefront of oncology research, and you thrive in a collaborative, cross-functional environment, we'd love to hear from you. This is a fantastic opportunity to apply your expertise in medical writing to a meaningful project with real-world impact.