Principal Spec Pss
7 days ago
Qualification:
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
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
**Labcorp is proud to be an Equal Opportunity Employer**:
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