Director, Regulatory Information Management

vor 1 Woche

Home Office, Schweiz BeiGene Vollzeit

General Description:


The Director, RIM is responsible for partnering with internal and external stakeholders in executing the RIM strategy and vision for the organization.

This includes activities related to RIM resources, planning and budgeting (in partnership with IT), for key systems implementation/upgrade, monitoring and analysis of submission and registration information, and metrics reporting.

This role will have global responsibility ensuring internal business processes and relevant regulatory guidelines & timelines are considered for implementation of BeiGene systems and allied processes.


Essential Functions of the job:
The Director will have primary responsibility in RIM Data Management Standards, Data Governance & Operations.

A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with other Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and cross-functional stakeholders (e.g., IT, Clinical, Nonclinical, Quality).

Identify opportunities within the RIM platform, to enhance compliance, efficiency, and reporting. Responsible for supporting all RIM Reporting and Analytics needs across Global Regulatory Affairs.

Responsibility:

  • Lead the efforts to align business processes to a RIM enterprise data strategy.
  • Lead the scoping and implementation of IDMP/XEVMPD in the RIM system.
  • Lead implementation/ maintenance, and governance of E2E RIM program: plan, configure and manage E2E RIM implementation.
  • Ensure users requirements are adequately documented and serve as the basis for system continuous improvement, reengineering, and/or new system selection.
  • Partner with crossfunctional business functions, along with IT, in RFI/RFP efforts for system implementation or update/reconfiguration due to evolving internal business needs, new electronic standards or health agency requirements.
  • Implement a robust RIM data governance model and support the oversight process. 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 interactions and country/regional product release.
  • Support the GRO RIMT Change Management Program initiatives, to assist with the change request process for the RIM system
  • Participate in and monitor industry forums and user groups, and agency information sources, to help identify and influence best practices.
  • Support the management of submission records and associated global product registration records.
  • Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.
  • Lead initiatives to integrate Regulatory information and records globally and for acquired assets and products.
  • Monitor emerging electronic standards or health agency requirements, assess business impact and define roadmap for addressing them.
  • Lead and support Regulatory Operations Intelligence related to industry technology platforms and processes.

Accountability:

  • Regulatory and registration data/records process integration and optimization.
  • Implementation and management of a comprehensive data model, master data and ongoing maintenance or improvement in compliance with emerging health authority requirements, industry best practices, and electronic standards.
  • Business process continuous improvement ensuring stakeholder, process and system alignment in compliance with evolving electronic data standards and submission of structured data. This may include reengineering or replacement of existing systems.
  • Postproduction support for the Regulatory Information Management (RIM) systems used within BeiGene.

Budget Management:

  • Collaborate with management and IT partners to plan for appropriate resource (FTE, contractors) and system budget, as requested.

Resource Management:

  • Responsible for task and performance management of employees to include, but not limited to, biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking and regular 11 meetings.
  • Collaborate with IT Business Partner to manage vendor relationships including tactical and strategic projects, issue resolution and contract negotiations.

Supervisory Responsibilities:
Yes

Requirements:

Computer Skills:

Expert knowledge:

  • Microsoft Office and Adobe systems
  • Document management systems (e.g. Documentum, Veeva Vault, etc.)
  • Regulatory information management systems (e.g. Calyx InSight, IQVIA RIM Smart, CARA, Veeva Vault RIM, etc.)
  • Collaboration Tools (e.g. SharePoint, etc.)
  • Labeling and eCTD Publishing, Viewing and Validation Tools (e.g Calyx, Veeva, Lorenz)
  • Offtheshelf and plugin software (e.g. StartingPoint Templates, DXC Toolbox)

Education Required:
Bachelor's degree required. Computer science field a plus

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