Medical Writer

Key Responsibilities

• Develop, write, and edit clinical and regulatory documents related to oncology clinical trials, including but not limited to:
  • Clinical study protocols and amendments
  • Investigator brochures
  • Clinical study reports (CSRs)
  • Informed consent forms
  • Briefing documents
  • Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
• Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to ensure content accuracy and consistency
• Interpret and synthesize complex clinical and scientific data into clear, concise, and scientifically sound documents
• Ensure all documents comply with ICH guidelines, regulatory requirements, and internal SOPs
• Participate in strategic planning and document timelines
• Mentor junior medical writers or contractors as needed
• Stay current with therapeutic area developments, industry trends, and regulatory guidance

Qualifications

• Advanced degree (PhD, PharmD, MD, or MSc) in life sciences, medicine, or a related field
• Minimum 5 years of medical writing experience, with at least 3 years focused on oncology clinical trials
• In-depth understanding of oncology disease areas and clinical endpoints
• Extensive experience in authoring documents for Phase I–III oncology trials and regulatory submissions
• Strong knowledge of ICH-GCP, FDA/EMA guidelines, and clinical trial processes
• Excellent written and verbal communication skills
• High attention to detail, strong analytical skills, and ability to manage multiple projects under tight deadlines
• Proficiency with document management systems and MS Office Suite; experience with templates and style guides