RIM Data Quality Associate Manager

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:  

The Associate Manager (AM), Regulatory Information Management (RIM) will serve as the global knowledge-center for the Regulatory Information Management System (RIM) Data Quality & Reporting.  The AM will partner with key RIM data owners, RegTech, & RIM leadership in executing the RIM strategy to maintain the BeiGene RIM system as the authoritative source for regulatory data. The AM will ensure compliance with all operational data quality processes and data remediation activities related to RIM globally. The AM, RIM, will assist in maintaining and monitoring end-to-end (E2E) Regulatory data/information (integration, optimization, input, curation, quality, governance, and standards, and be responsible for analysis and reporting. As well, the AM may provide input for business process re-engineering to ensure stakeholder/partner, process, and system alignment in compliance with evolving electronic data standards. This role which reporting to the Senior Manager RIMT is a critical member of the RIM Data Quality team within RIM, contributing to the vision, mission, strategy and infrastructure of the Global Regulatory Operations department.

Essential Functions of the job:

Accountable and responsible for building and maintaining relationships with Regulatory and functional groups within and outside of the department including RegTech, business partners (e.g. CMC, Labeling SMEs) to ensure effective communication and efficient data monitoring as outlined below:

• Execute data quality reports at a defined cadence and work with data owners to resolve discrepancies. 

• Manage data quality reports including minor and major updates. 

• Provide ad hoc report outputs related to data quality, remediation, or governance. 

• Maintain an effective relationship with all data owners globally to enhance BRIM adoption and BRIM process adherence. 

• Contribute to the creation and management of E2E Regulatory data/information within the system(s). Provides oversight for data completeness, curation, quality, standards, reporting and analysis.

• Support the implementation and management of a comprehensive data model, master data, and ongoing maintenance or improvement in compliance with emerging health authority requirements or electronic standards.

• Ensure data availability in a complete, accurate, and timely manner through use of data quality monitoring methods for systems from planning of regulatory activities through Health authority interaction and to country/ regional implementation.

• Provide oversight for ongoing information management of submission records and associated global product …