Business Data Analyst II supporting SAS/SQL - based CCAR Y14 reporting solutions at Truist. Ensuring accuracy and regulatory alignment of CCAR Y14 data through reporting enhancements and analysis.
About the role
- Data Analyst focusing on Post-Market Surveillance at PolyNovo, an innovative medical tech company. Delivering reports that highlight key data, trends, and opportunities for continuous improvement.
Responsibilities
- Responsible for establishing or supporting general guidelines and recommended procedures for utilizing statistical techniques in the analysis of PNV products and processes
- Responsible for establishing or maintaining requirements for analyzing quality data for the purpose of continuous improvement including identifying potential quality problems
- Maintains post-market quality data integrity by limiting data access to trained and authorized users based on their roles and responsibilities
- Extracts and analyses data from the complaint management system, GxP systems, and other relevant sources to produce actionable reports
- Supports complaint handling (intake, coding, investigations, closure) and collaborates with department stakeholders to understand their needs and translate them into actionable analytics activities
- Develops analytical methods and implements a consistent data analytics strategy in accordance with Post-Market regulatory requirements
- Extracts, analyses, and presents data from the complaint management system and other GxP systems to support global regulatory submissions, market registrations, and renewals
- Uses software and data tools to create queries, dashboards, charts, and other outputs
- Performs various activities to ensure accuracy and usability of data, including data gathering, data preparation, data transformation, and data visualization
- Uses statistical tools to analyses data, make acceptance decisions, and improve process
- Collaborates with cross-functional stakeholders to achieve regulatory and business objectives
- Demonstrates the capability to lead meetings, support projects, and deliver presentations effectively
- Utilizes business acumen, collaboration, and inquisitiveness to understand problems and identify which data can be utilized to diagnose potential causes
- Evaluates data and identifies trends to develop solutions
- Assists in various PMS and quality systems analysis, including investigations as necessary
- Escalates identified safety and quality concerns and/or potential concerns
- Maintains up-to-date knowledge of relevant regulations, data privacy, and security requirements to ensure compliance in data collection and reporting
- Ensures adherence to all Federal, State, local, and company regulations, policies, and procedures
- Possesses knowledge of medical device quality systems and related processes to effectively utilize the best available data for reporting requirements
- Participates in audits and inspections, including performing data queries as requested
- Assist PNV Quality Affairs as needed
Requirements
- Bachelor’s degree or higher in statistics (preferred), data analytics, data science, or a data related discipline
- Experience with data and analytics in a regulated environment required
- Advanced degrees or qualifications in Quality Assurance, Data Analytics, or programming tools are preferred
- Minimum of 2-3 years of experience in a data science, data analytics, quality, and/or regulatory affairs position
- Knowledge of global Medical Device, Pharmaceutical, or Combination product regulatory requirements
- Experience pulling data and reports to solve business problems
- Team player while demonstrating effective negotiation and influence skills for critical compliance related topics
- Must be organized and able to coordinate activities with internal departments and outside stakeholders
- Good interpersonal, verbal and written communication skills
- Ability to effectively negotiate and build collaboration amongst individuals
- Experience with regulatory inspections including interacting with auditors and supporting regulatory audits is preferred
- Experience with working in validated quality software
- Working knowledge of device and/or pharmaceutical manufacturing processes desired
Benefits
- Rewards platform with access to discounts at over 450+ Australian retailers
- Paid parental leave for primary and secondary carers
- Nurture Days
- Salary packaging including novated car leasing
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