Director - Inspection Readiness and Clinical Oversight

September 15

Apply Now

Receive Emails with Similar Jobs

Viatris

WebsiteLinkedInAll Job Openings

Pharmaceuticals • Generics • Anesthesia & Pain Management • CNS • Cardiovascular

10,000+

Description

• Accountable for the development, implementation, and maintenance of inspection readiness strategy • Collaborate across Viatris to minimize departmental risks • Support clinical operations for regulatory agency inspections • Oversee clinical oversight activities for CRO compliance • Assist in monitoring oversight plans development • Provide guidance on ICH/GCP and SOPs to global teams • Participate in Clinical Operations processes development

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 • 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 the Microsoft suite of programs • Good understanding of clinical trial related software • Ability to travel up to 25% • Supervisory responsibilities experience

Benefits

• Competitive salaries • Benefits and an inclusive environment • Opportunity to make an impact • Equal Opportunity Employer