Bachelors/Masters/PhD degree in Medicine or Alternative medicine or Pharmaceutical science or Sciences
? 5 plus years of overall work experience in the functional area with at least 2 years in Peer review/Quality review of any of the reports for global regulatory submissions and some experience in CAPAs and trending.
? Experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports
Keyskills:
Regulatory and Medical Writing, Quality Assurance
? Technical proficiency with Microsoft Office suite of applications
? Good understanding of various regulatory reports and ICH-GCP guidelines
Job description:
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
? Ensure compliance of operations with governing regulatory requirements
? Create, maintain and assume accountability for a culture of high customer service
? Nurture and sustain an environment of continuous learning
? Contribute to building and growing the Practice through responsibilities related to Quality, Process Excellence and Training
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