• Job Description

  Req#: R21082

  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 Sr. Manager, Regulatory Information Management, RIMT 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 a global scope ensuring internal business processes and relevant regulatory guidelines & timelines are considered for implementation and post implementation support of BeiGene systems and processes.

  Essential Functions of the job:

  The Sr. Manager, Regulatory Information Management, RIMT 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 cross-functional 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.
  • Support the implementation and maintenance of 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 Regulatory Information Management & Technology (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, ensuring that stakeholder and system impact analysis are embedded into an overall action and/or project plan
  • Support the management of submission records and associated global product registration records.(e.g. Submission Correspondence process)
  • Track alignment of business processes and models across all business functions supporting global Regulatory product registrations.
  • Lead and/or support 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 processes related to industry technology platforms and processes.
  • Work closely with Global Regulatory Operations Project Manager to ensure RIM implementation plans (e.g. migration, data QC) are embedded into the overall system implementation plan and/or system upgrade project plans

  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.
  • Post-implementation leadership for the Regulatory Information Management (RIM) systems used within BeiGene.

  Resource Management:

  • Support the identification of resourcing needs and hiring of both internal FTE and contractors per need identified by the Global Regulatory Operations management team,
  • Collaborate with IT Business Partner to manage vendor relationships including tactical and strategic projects, issue resolution and contract negotiations.

  Supervisory Responsibilities: Yes

  Education Required:

  Bachelor’s degree preferred but equivalent experience considered.

  Graduate degree preferred.

  7+years’ experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment with demonstrated ability to present and articulate requirements. Experience in systems management or implementation in the life sciences industry or regulated industry.

  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)
  • Off-the-shelf and plug-in software (e.g. StartingPoint Templates, DXC Toolbox)

  Other Qualifications:

  • Working knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.
  • Working knowledge of drug development and submission requirements
  • Demonstrated ability to facilitate, lead and manage the establishment of procedures
  • Excellent written, verbal, and interpersonal communication skills; able to communicate effectively cross-functionally.
  • Able to work in a fast-paced environment and effectively manage workload and deliverables under pressure.
  • Experience with onboarding, developing and maintaining external partnerships with vendors, contracts to augment and/or lead RIM projects/programs
  • Experience with leading a global RIM, Data Management and/or Business Technology team,
  • Experience in working closely with IT business partners internally and managing medium to large scale technology projects (e.g. eDMS, eCTD publishing tools, tracking systems, etc.) from start to finish.
  • Experience in managing day-to-day administration of regulated systems.

  Travel:

  BeiGene Global Competencies

  When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

  We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

• About the company

  BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment.

Notice