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.