Clinical Trial Regulatory Specialist ensuring compliance and quality in regulatory submissions for clinical trials. Working in a team to deliver and provide expertise in core regulatory activities.
Responsibilities
Performs assigned activities within the CTRA team
Responsible for providing delivery and expertise in regulatory core submissions
Prepare the technical components of a regulatory core submission
Conducts Quality Control reviews of documents
Attends client meetings as needed
Requirements
Minimum of a BA or BS preferred
Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155)
Excellent presentation, documentation, influencing, and interpersonal skills (both written and spoken)
Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet
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