Oncology Medical Writer

Job Summary

A company is looking for a Medical Writer (Part-Time).

Key Responsibilities

• Develop and edit oncology trial documents, including study protocols and consent forms
• Prepare regulatory submissions content for INDs, NDAs, and BLAs
• Collaborate with teams across Clinical Development and Regulatory Affairs to ensure document accuracy

Required Qualifications

• Advanced degree (PhD, PharmD, MD, MSc) in life sciences or related field
• 5+ years of medical writing experience, including 3+ years in oncology trials
• Expertise in NSCLC and breast cancer, especially small molecule kinase inhibitors
• Strong knowledge of oncology, clinical endpoints, ICH-GCP, and FDA/EMA guidelines
• Experience in biotech, pharma, or CRO environments