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well as external regulatory guidance. Manages all aspects of document development process and leads project teams through process. Collaborates with project teams, subject matter experts, and quality lines to ensure
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wide range (non-routine) complex audits (minimal to no oversight - as needed). Execute audit strategy and lead process audits. Act as a reviewer of audit reports from outsourced or routine audits. Assess
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development and execution of control plans Utilize operational performance data to characterize state of control, improvement opportunities and drive process and system optimization Deliver effective business
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regulations Independently conducts wide range of routine/(non-routine) complex investigator site audits (minimal to no oversight - as needed) Executes audit strategy, leads/supports process audits, and may
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cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. POSITION SUMMARY As part of the Clinical Data Sciences (CDS) group
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cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. POSITION SUMMARY As part of the Clinical Data Sciences (CDS) group
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Sciences group by way of process improvement. Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related
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, approving sites, and assessing site activation plans Accountable and responsible to ensure PTMF setup for Study management and Country/Site level documents Inputs into the IQMP risk planning process for
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experience in Automation Engineering Experience with process controls equipment; design and debugging skills Broad understanding of systems architecture and operations, and related components Excellent project
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cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. ROLE SUMMARY This position will provide statistical support for