Regulatory Affairs Data Governance and Quality Capability Lead
Regulatory Affairs Data Governance and Quality Capability Lead
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 132300 - 245700
1 Vacancy
Job Description
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
#LI-Hybrid
Key Responsibilities:
- 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- Expert contributor to influence draft guidance on data standards / specifications / implementation from Health Authorities and Trade Organizations.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
Essential Requirements:
- Bachelors degree masters; 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
Desirable Requirements:
- 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
The salary for this position is expected to range between $132300 and $245700 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other benefits. In addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$132300.00 - $245700.00Skills Desired
Data Analysis Documentation Management Lifesciences Proactivity Process Improvement Regulatory Compliance Waterfall ModelEmployment Type
Full-Time
