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.