09 feb
Gsk
Xico
**Site Name**: Poznan Grunwaldzka, Mexico City Artz Pedregal Flex, Mexico City Torre Mitikah, Mississauga Milverton Drive
**Posted Date**: Feb 5 2025
**Senior Manager, Reporting and Analytics**
The Global Regulatory Operations Reporting Senior Manager at GlaxoSmithKline (GSK) is responsible for leading and managing the development, implementation, and maintenance of reporting services that support regulatory operations on a global scale.
These services are delivered in a DevOps model leveraging Power BI and connecting to Regulatory data via GSK's Data Fabric and Code Orange platforms.
This role ensures the delivery of high-quality, compliant,
and timely regulatory reports that meet the business needs and regulatory requirements across various regions.
The manager collaborates with cross-functional teams, including Regulatory Affairs, Tech, Quality, and other stakeholders, to drive continuous improvement in reporting processes and data integrity.
By leveraging advanced analytics and innovative technologies, the Global Regulatory Operations Reporting Service Manager enhances GSK's ability to navigate the complex regulatory landscape, thereby supporting the successful registration, maintenance, and lifecycle management of GSK's products worldwide.
**Locations: Poland (Poznan, Warsaw), Mexico City, Milverton (Canada)**
**Key Responsibilities**:
- ** Leadership and Management**:
Lead a team of reporting analysts and specialists, providing guidance, mentoring, and support to ensure high performance and professional growth
- ** Reporting Strategy**:
Develop and implement a comprehensive reporting strategy that aligns with GSK's regulatory operations goals and objectives, ensuring compliance with global regulatory requirements
- ** Data Integrity and Quality**:
Oversee the accuracy,
completeness, and integrity of regulatory data, ensuring that all reports are compliant with internal and external standards
- ** Stakeholder Collaboration**:
Work closely with Regulatory Affairs, IT, Quality, and other cross-functional teams to understand reporting needs, gather requirements, and deliver effective reporting solutions
- ** Regulatory Compliance**:
Ensure all regulatory reporting activities comply with applicable regulations, guidelines, and standards, including FDA, EMA, and other global regulatory bodies
- ** Process Improvement**:
Continuously identify opportunities for process enhancements and efficiencies in regulatory reporting, implementing best practices and innovative solution
- ** Technology Utilization**:
Leverage advanced analytics, data visualization tools,
and other technologies to optimize reporting processes and deliver actionable insights
- ** Project Management**:
Manage multiple reporting projects simultaneously, ensuring timely and accurate delivery of regulatory reports and submissions
- ** Training and Development**:
Develop and deliver training programs for team members and stakeholders on regulatory reporting processes, tools, and best practices
- ** Risk Management**:
Identify potential risks in the reporting process and develop mitigation strategies to ensure continuous compliance and operational excellence
**Why you?
**
**Basic Qualifications**:
- A Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline is required
- Professional Certifications (preferred):
Relevant professional certifications such as Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or certifications in IT systems management or data governance are advantageous
- Experience delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems)
- Lead and participated in Business Change Teams delivering IT solutions for the business
- Extensive experience of working within a regulated project delivery environment
- Ability to communicate and provide assistance and support on both sides of the Business-IT interface
- Proven ability to interact effectively with senior managers within the organization
- Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development
- Experience in Business Analysis and Business Process Design
- Fluent and able communicator in English and local language
- Strong communication and influencing skills
- Ability to self-manage the work and prioritize effectively
- Service orientation, customer-focused
- Good team worker, but with confidence to lead when appropriate
- Good understanding of IT lifecycle, processes and quality management
- Extensive Experience with Power BI development and support
- Experience with Azure data products, Snowflake, and Denodo are highly desirable
- Experience with Python is desirable
- Software and System Experience
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