
Pharmaceutical Quality GCP EMA Mock Inspector β Consulting
Posted 4 days ago

Posted 4 days ago
This is a fully remote position, open to applicants in United Kingdom.
β’ Perform mock inspections in accordance with Good Clinical Practice (GCP), which includes planning, setting agendas, conducting physical assessments, providing coaching, and writing reports.
β’ Assess Sponsors, Contract Research Organizations (CROs), and investigator sites.
β’ Create detailed inspection reports that outline findings.
β’ Deliver written inspection reports in English.
β’ Collaborate effectively with clients to uphold quality standards.
β’ Become a member of Advarra's consultant network for projects based in the EU.
β’ At least 10 years of experience in Quality Assurance and/or Good Clinical Practice (GCP).
β’ A minimum of 5 years of experience in GCP inspections.
β’ Proven work experience with any European Health Authority.
β’ Demonstrated ability to lead, develop, and execute investigation activities.
β’ Proficiency in English communication at a B2 level, both verbal and written.
β’ A Bachelor's degree is required.
β’ Excellent interpersonal skills and ability to engage with clients.
β’ Strong analytical, problem-solving, communication, and report-writing abilities.
β’ Capacity to work collaboratively across various departments and interact with both internal and external stakeholders.
β’ Registration is necessary for consideration unless you are already part of the consultant network.
β’ An inclusive and collaborative work environment.
β’ A commitment to respecting diverse perspectives.
β’ The chance to make a significant impact in advancing clinical research.
Horizon Connect @ Wall BCBSNJ
The Baldwin Group
Connection
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