Engineering

Freelance Medical Writer

  • Location

    Münchendorf

  • Sector:

    Pharmaceuticals

  • Job type:

    Contract

  • Salary:

    €60 - €70 per hour

  • Contact:

    Max Jones

  • Contact email:

    m.jones@ioassociates.eu

  • Job ref:

    BBBH164882_1753437125

  • Duration:

    4 Months

  • Startdate:

    01/08/25

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.