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Patient Oriented Programs Lead

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This role is an operational governance and oversight function to ensure Patient Oriented Programs (POP) are initiated and executed according to applicable quality standards by the respective POP owners.

The position holder acts as a single point of contact for the global POP office and has a matrix reporting line to the Global POP Champion.

Skills:
Oversee Patient Oriented Program (POP) set-up, initiation and execution together with local / franchise POP partners at the respective unit to meet quality & compliance as well as business objectives
Act as the subject matter expert for all POP related questions at the respective unit
Ensure training resources are available at the respective unit. Conduct or organize workshops, trainings and best-practice sharing sessions for associates involved in POPs at the respective unit
Facilitate process adherence in close collaboration with POP owners, the drug safety responsible person and quality assurance
Ensure the necessary POP quality standards are in place at the respective unit
Provide support and direction to POP owners for program initiation and execution as well as on vendor selection and vendor quality assessment
Oversee quality control activities required according to POP classification
Perform POP quality checks to ensure adherence to company processes and compliance to pharmacovigilence requirements; report results to global POP office and to respective unit management
Ensure appropriate action is taken, in case POP failed the quality check. Liaise with quality assurance, drug safety and the global POP governance board as required to determine the corrective and preventive action (CAPA) plan and provide oversight and status update to global POP office and POP governance board. Ensure adequate escalation of issues to management and the timely resolution of the CAPA plan
Ensure POP database is maintained accurately and timeliness of data is kept by POP owners, the drug safety responsible person and other functions
Officially close POPs after final quality check
Liaise with the global POP office on a regular basis to ensure that any global communication is cascaded appropriately within the respective unit and to enable that local feedback reaches the global POP office
Provide input to further enhance global business processes and quality standards for POPs
Together with quality assurance and drug safety ensure audit / inspection readiness for POPs and participate in vendor audits, if required

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