Governance Risk Assessment Specialist
Katalyst HealthCares & Life Sciences
- Lake County, IL
- Permanent
- Full-time
Supports the activities and initiatives of Convergence Governance team to implement and manage the Governance Risk Assessment activities including its policies, procedures, and programs as well as leading the different risk assessment job tasks. Also, perform the analysis of data and monitor Risk Management process. This individual liaises with business process stakeholders across organizations and geographies to build, sustain and leverage data governance risk assessment across Convergence supported functions.
Responsibilities:
- Monitors Risk Assessment Program for Convergence in compliance with policies and procedures in addition to all federal/state/global/local and pharmaceutical regulations.
- Ensure accuracy and completeness of documentation in accordance with Risk Assessment policies and procedures.
- Participates in Global and Local Risk Management documentation changes and change control activities which have an impact to Convergence.
- Actively manage document processes within the Governance Risk Assessment System (Gov360) by ensuring timely updates and compliance with risk assessment standards.
- Coordinate directly with stakeholders to facilitate document submissions, while following up on and tracking the implementation of Risk Management action items.
- Update Risk Assessment documentation per local and global requirements and maintain organized and detailed records.
- Prepare and update Risk Management Metrics as specified in local and/or global procedures.
- Prepare Risk Management reports (e.g., Cross-contamination reports, Risk Control documents).
- Provide Governance training as required.
- Provide support with the Training and Documentation area functions and all related activities.
- Provide support in site metrics (e.g., Dashboard, Management Reviews).
- Provides support for Compliance activities (e.g., internal audits). Support investigation activities, identify trends, collect data for timely resolution of exception events (e.g., Investigations, complaints, etc.).
- Responsible to work cross functional with the different Compliance functions to align Convergence data Governance across the different policies and procedures.
- Bachelor's degree in science, technology, law, ethics, compliance, risk management, or a related field. A master's degree or professional certification is preferred.
- Two years of experience within the pharmaceutical, biotech, medical device companies or healthcare industry.
- Minimum 5 years of experience in Information Risk Management, regulatory compliance, or equivalent.
- Strong project management, collaboration, communication, and organizational skills. Adapt to daily changes and shifting priorities in a fast-paced environment.
- Experience of working with internal clients across departments.
- Ability to handle multiple tasks, prioritize them, and carry them out independently while being mindful of the big picture.
- Basic understanding of data storage and security principles.
- Ability to identify problems, analyze data and present solutions.
- Skilled at uncovering underlying issues and managing ambiguity in complex situations.
- A self-starting, self-motivated individual with strong interpersonal skills and demonstrated leadership ability.
- Excellent written, oral, and computer (i.e., Microsoft excel) skills, as well as demonstrated comfort with information technology. In-depth IT knowledge is not required, but enthusiasm to self-learn are vital to the position.
- Preferred broad knowledge of information management and protection laws, regulations, and best practices.
- Preferred information governance experience, including in the areas of personal information, company information, systems, and infrastructure.