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RA Data Governance and Quality Capability Lead(m/w/x)

Novartis
Basel

You lead a team focused on data governance and quality, developing strategies and roadmaps while collaborating with various stakeholders to ensure effective data management and compliance with standards.

Anforderungen

  • •Bachelor's degree or master's degree
  • •8+ years of relevant industry experience
  • •Strong understanding of Data Strategy
  • •Strong network in regulatory organizations
  • •Advanced knowledge of data standards
  • •Strong understanding of regulatory requirements
  • •Excellent business writing and communication skills
  • •Extensive experience leading cross-functional teams
  • •Strong strategic problem-solving skills
  • •Strong negotiation skills

Deine Aufgaben

  • •Lead a team to align with organizational goals.
  • •Serve as Data Governance and Quality Capability Lead.
  • •Develop data roadmap with cross-functional teams.
  • •Create and implement data management and quality strategy.
  • •Influence guidance on data standards and specifications.
  • •Prepare analyses on impact to internal data processes.
  • •Collaborate to develop RA Data Governance structures.
  • •Oversee vendors in collaboration with IT teams.
  • •Manage Data Governance and metrics reporting.
  • •Make decisions impacting capability with stakeholders.

Original Beschreibung

# RA Data Governance and Quality Capability Lead **Basel (City)** | **Full time** **Job Description Summary** As a member of the RA Data Strategy and Management Platform team, the Data Governance and Quality Capability Lead is responsible for independently driving and implementing data standards and strategies for emerging data-driven HA requirements, and relevant systems’ governance processes across all domains and functions, in support of the NVS global product portfolios to improve data maturity according to RA business objectives. The Data Governance and Quality Capability Lead is accountable to drive harmonization and continuous improvement of Data Governance related activities and initiatives in close alignment with internal and external stakeholders to improve data maturity according to RA business objectives. The Capability Lead will drive the Centralized Data Quality Management culture in Regulatory Affairs and ensure Data Quality consistency, correctness and completeness across all applicable RA systems and platforms. **Job Description** # Major accountabilities: * Lead a team to ensure alignment with organizational goals and business priorities related to Data Governance and Quality * Serve as Data Governance and Quality Capability Lead for RA and as the point of contact for GDD Data team * Lead RA cross-functional teams to develop data roadmap, in alignment with cross-domain Data Governance boards * Accountable to create and implement data management and quality strategy * Expert contributor to influence draft guidance on data standards / specifications / implementation from Health Authorities and Trade Organizations. Prepare interpretative analyses about impact on internal data and digital processes. * Collaborate with Development Data Management and DDIT partners to develop and implement RA Data Governance structures (boards) and policies, ensuring involvement of Business Process Owners (BPOs) and business SMEs. * Oversee vendors at the Capability level, in collaboration with IT and the External Partnerships Teams * Manage Data Governance and metrics reporting on data operating model throughout the DQM lifecycle * Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders # # Minimum Requirements: * Bachelor’s degree, master’s; Advanced degree in life science, pharmaceutical, technology or data science preferred * 8+ years of relevant industry experience * Strong understanding and direct relevant experience with the Data Strategy and Management landscape of pharmaceutical regulatory affairs and Regulatory Information Management * Strong network and exposure to the external environment and ability to represent company and influence in Trade organizations (e.g., EFPIA, PhRMA), International Organizations (ISO), and collaboration with regulators (e.g. ICH, EMA SPOR), or consortiums * Advanced knowledge of worldwide evolving external data standards as well as drug registration and approval processes and related document format requirements and in-depth knowledge of good Regulatory compliance and intelligence practices, policies, procedures * Strong understanding of regulatory requirements and structured data submissions standards and initiatives * Excellent business writing, communication and effective presentation skills. * Extensive experience leading meetings, driving change and cross-functional teams * Strong strategic problem-solving skills and ability to innovate, analyze and navigate un-charted territory without clear precedent, ability to troubleshoot effectively, accurately and independently. * Strong negotiation skills **Skills Desired** Data Analysis, Documentation Management, Lifesciences, Proactivity, Process Improvement, Regulatory Compliance, Waterfall Model
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