Director - Inspection Readiness and Clinical Oversight
November 13
Description
• Accountable for the development, implementation, and maintenance of inspection readiness strategy • Collaborate across Viatris to minimize departmental risks • Support clinical operations and conduct mock inspections • Oversee and conduct oversight visits to CROs and clinical investigators • Provide in-depth guidance of ICH/GCP to global clinical operations personnel • Participate in development and review of Clinical Operations processes
Requirements
• Minimum of a bachelor’s degree (or equivalent) • Minimum of 8 years of clinical project management experience • Experience in organizational defense of submissions to regulatory authorities • Must possess in depth level of knowledge regarding global clinical trial operations • Expert level knowledge and interpretation of Regulatory Agency regulations • Comprehensive knowledge of drug development and clinical trial management • Strong communication, organization, planning, analytical, and problem-solving skills • Experience with Microsoft suite of programs • Good understanding of clinical trial related software • Ability to travel up to 25%
Benefits
• Competitive salaries • Competitive benefits • Inclusive environment
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