Requisition ID: REG004395
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125:year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Health Registration Management Regional Lead for Latin America is responsible for ensuring high quality data in Global Regulatory Affair's (GRA) enterprise system to manage core regulatory information (the ORION system). The HRM Regional Lead will support all countries in Latin America and will be responsible for the data quality of that Region to effectively drive business operations throughout the enterprise. The Latin America Regional Lead will be responsible for understanding the business processes supported by the tool and where necessary, adapting those procedures to align with country:specific needs/requirements within the Region. Subsequent to change initiatives, the Regional Lead will ensure users are trained appropriately to maintain high quality data maintenances. The Regional Lead will be responsible for evaluation of regional data from the ORION data:monitoring plan and creating action plans for the region to address data quality issues. The HRM Regional Lead will be the primary contact for the regional users with regards to questions on system usage and process. The HRM Regional Lead will represent regional needs for system and process changes on the ORION Change Control Process.
The position could be based in
Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Panama, Peru or Puerto Rico. Does not include relocation assistance.
Responsibilities:
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Serves as primary contact for ORION users in the countries with regards to system usage and support.
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Responsible for providing communication to the Regional Communities of Practices for process and system changes.
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Represents the needs of the Region on the ORION Change Control Board to ensure that changes are appropriate for the regions.
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Works closely with Regional RAI Lead, Country Leads, and Regional Quality and Compliance to agree and understand rationale for changes necessary to support the regions.
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For low:frequency, high:complexity system interactions the HRM Regional Lead will provide direct support together with the system users in the region to correctly enter data into the system.
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Assists in developing and facilitating regulatory training for ORION users in the region including on boarding and refresher training.
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Participates in the evaluation of metrics from the ORION data:monitoring plan to determine where process changes, communications, and trainings/retrainings may be needed to improve overall data quality.
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Participates or leads a change initiatives to represent regional needs for system and process and to improve overall functioning of system within the region, including participating in user acceptance testing representing the country usage.
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Work closely with ORION Business Process Lead to adapt or revise processes to support regional needs. Qualifications
Requirements:
Education Minimum Requirement:
dirltr:
:Bachelor's Degree. Degree in Science, Engineering or Pharmacy, preferred. Masters Degree, preferred.
Required Experience and Skills:
:Seven (7) or more years of professional experience.
:Five (5) or more years of experience in the Regulatory area in the pharmaceutical industry.
:Experience with technical systems related to regulatory activities in the pharmaceutical industry (example ORION, Appian Tools, RCAM).
:Broad range of knowledge of regulatory processes.
:Knowledge of Regulatory Filing procedures and/or Health Authority Registration process.
:Demonstrated experienc
