Consultant

Job Description

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• Monitor country/region-specific MI escalation mailboxes for Europe, the NorAm and emerging markets
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• Maintain a thorough understanding of country-specific prescribing information, pack inserts, product monographs, and standard response documents for each marketed product in different countries
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• Review and record the escalated MI inquiries from Eversana in each mailbox (from Europe, the NorAm and emerging markets)
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• Create a scientific response to each medical inquiry in consultation with the TA leads, the MI lead and the medical writing team
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• Coordinating with cross-functional teams, including but not limited to Quality, RND, Regulatory, PV and other functions as needed for input to respond to the inquiries
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• Create a standard response document for complex MI inquiries in consultation with TA leads, MI lead and medical writing team
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• Ensure the MI responses are Scientific, accurate, fair and balanced and referenced to the approved product prescribing information/labelling and country-wise regulatory requirements
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• Ensure MI responses are only scientific in nature, that address the exact nature of the inquiry, and that the response is not promotional in nature
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• Ensure to send the final drafted response to the MI lead for review and implement the comments/changes before sharing the final response
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• Ensure 100% all escalated medical inquiries are responded to within 7 working days
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• Ensure to record and provide a monthly report of all inquiries received and addressed from each region (from Europe, the NorAm and emerging markets)
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• Ensure implementation of corrective actions for errors that were identified in the response/process or deviations
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• Maintain the lifecycle of the standard response documents in terms of annual revision, review and creating a final clean version for review and approval by the MI lead
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• Provide information to the Medical affairs/other cross-functional teams in terms of analysis/ other relevant medical information-related requests on a need basis
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• Support the MI lead in terms of medical information operations management with Eversana and internal cross-functional teams
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