and regulatory requirements, client's customers, markets, business operations, and emerging issues. Oversees project-related... of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses...
. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development... Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie...
and regulatory filings; Author and/or provide senior review of clinical protocols, medical affairs and regulatory documents/filings... and implementation. Liaise with relevant stakeholders in clinical, regulatory, and commercial to coordinate and align biomarker...
Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product... or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation activities on a global level...
Department Health Affairs AutoReqId 82244BR Status Part-Time Standard Hours per Week 20 Job Posting... Category Administration Job Posting Description Department Summary: As a global leader in the advancement of pediatric...