Associate Director, Medical Writing

Taiho Oncology is seeking an Associate Director, Medical Writing to join their team. The incumbent will be responsible for authoring documents submitted to Regulatory Authorities, including Clinical Study Reports, Investigator Brochures, and Protocols. The position requires a strong understanding of regulatory requirements, medical writing processes, and experience in oncology. The company offers a competitive salary range of $194,650 - $229,000 annually and a comprehensive benefits package.

Requirements

• Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience
• Minimum of 8 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents
• Extensive previous experience in Medical Writing in clinical drug development, preferably some experience in oncology
• Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations
• Knowledge of template development, document management systems and requirements
• Experience developing and implementing medical writing processes for all stages of clinical development
• Strong working knowledge of medical writing requirements and document components

Benefits

• 401(k) eligibility
• Paid time off benefits
• Parental leave
• Annual bonus/incentive comp plans
• Potential long term incentive plan
• Discretionary awards