Skills & Services
• Outcome-oriented, focused, with superior training in drafting and reviewing regulatory, pharmacovigilance, safety, scientific, toxicological, and legal documents for the United
States and European agencies, as well as regulatory bodies
• Highly experienced in preparing regulatory and safety documents to support the development of oncology agents in clinical studies
• 15 years of research experience with a strong background in infectious disease (malaria), cell biology (organelle biogenesis), biochemistry, and genetics
• Excellent standard of written and oral communication skills in German and English
• Detail-oriented with exceptional organizational, analytical, and creative problem-solving skills
• Drafting, reviewing, and editing regulatory, pharmacovigilance, safety, scientific, and toxicological documents