Business Process Consultant - FDA Real World Data - RWD - Readiness - Remote
About the position
Optum Insight is improving the flow of health data and information to create a more connected system. We remove friction and drive alignment between care providers and payers, and ultimately consumers. Our deep expertise in the industry and innovative technology empower us to help organizations reduce costs while improving risk management, quality and revenue growth. Ready to help us deliver results that improve lives? Join us to start Caring. Connecting. Growing together.
The Business Process Consultant will establish and maintain FDA Real World Data (RWD) readiness across OLS (Optum Life Sciences), providing end to end ownership of processes, documentation, and quality practices to ensure alignment with evolving regulatory expectations.
You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. For all hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week.
Responsibilities
• End to End Business Process Ownership
• Creates, controls, and improves business processes across functional areas
• Leads process design and implementation of processes
• Owns and maintains end to end FDA RWD readiness processes
• Designs and governs compliant RWD workflows across Product, Data, Engineering, Privacy, and Quality
• Process Excellence & Continuous Improvement
• Diagnoses process improvement opportunities
• Develops solutions using principles of process excellence
• Identifies gaps and risks against FDA RWD guidance
• Implements scalable, auditable improvements to RWD processes
• Sustains readiness through continuous monitoring and improvement
• Quality Reporting, Analysis & Audits
• Responsible for quality reporting, analysis, and audits
• Supports audit readiness
• Leads FDA RWD audit readiness, evidence collection, and remediation tracking
• Maintains inspection ready artifacts, metrics, and control documentation
• Partners with internal and external audit teams
• Quality Management (Total Quality Management - TQM)
• May design, facilitate, and evaluate quality improvement initiatives
• Establishes quality management practices for RWD (SOPs, controls, governance)
• Ensures alignment to internal QMS and regulatory expectations
Requirements
• 5+ years of experience in business process consulting, process improvement, quality management, compliance, or a related field
• 2 years of experience working in regulated environments (e.g., healthcare, life sciences, data governance)
• Intermediate to Advanced experience with technical writing (i.e. how to create process flows, SOPs using Visio, interview SME and create documented practices. Know how to write non-conformance and corrective actions)
• Intermediate experience with MS Office - Visio
• Demonstrated ability to communicate effectively on a regular basis with Compliance, Legal, Engineering and Data team stakeholders
Nice-to-haves
• Experience supporting quality reviews, audits, or regulatory readiness activities
• Familiarity with FDA Real World Data (RWD) guidance, or Real World Evidence (RWE) concepts
• Experience working within a Quality Management System (QMS)
• Experience working with SmartSheets
• All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy
Benefits
• In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements).
• No matter where or when you begin a career with us, you’ll find a far-reaching choice of benefits and incentives.
Apply tot his job
Apply To this Job
Optum Insight is improving the flow of health data and information to create a more connected system. We remove friction and drive alignment between care providers and payers, and ultimately consumers. Our deep expertise in the industry and innovative technology empower us to help organizations reduce costs while improving risk management, quality and revenue growth. Ready to help us deliver results that improve lives? Join us to start Caring. Connecting. Growing together.
The Business Process Consultant will establish and maintain FDA Real World Data (RWD) readiness across OLS (Optum Life Sciences), providing end to end ownership of processes, documentation, and quality practices to ensure alignment with evolving regulatory expectations.
You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. For all hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week.
Responsibilities
• End to End Business Process Ownership
• Creates, controls, and improves business processes across functional areas
• Leads process design and implementation of processes
• Owns and maintains end to end FDA RWD readiness processes
• Designs and governs compliant RWD workflows across Product, Data, Engineering, Privacy, and Quality
• Process Excellence & Continuous Improvement
• Diagnoses process improvement opportunities
• Develops solutions using principles of process excellence
• Identifies gaps and risks against FDA RWD guidance
• Implements scalable, auditable improvements to RWD processes
• Sustains readiness through continuous monitoring and improvement
• Quality Reporting, Analysis & Audits
• Responsible for quality reporting, analysis, and audits
• Supports audit readiness
• Leads FDA RWD audit readiness, evidence collection, and remediation tracking
• Maintains inspection ready artifacts, metrics, and control documentation
• Partners with internal and external audit teams
• Quality Management (Total Quality Management - TQM)
• May design, facilitate, and evaluate quality improvement initiatives
• Establishes quality management practices for RWD (SOPs, controls, governance)
• Ensures alignment to internal QMS and regulatory expectations
Requirements
• 5+ years of experience in business process consulting, process improvement, quality management, compliance, or a related field
• 2 years of experience working in regulated environments (e.g., healthcare, life sciences, data governance)
• Intermediate to Advanced experience with technical writing (i.e. how to create process flows, SOPs using Visio, interview SME and create documented practices. Know how to write non-conformance and corrective actions)
• Intermediate experience with MS Office - Visio
• Demonstrated ability to communicate effectively on a regular basis with Compliance, Legal, Engineering and Data team stakeholders
Nice-to-haves
• Experience supporting quality reviews, audits, or regulatory readiness activities
• Familiarity with FDA Real World Data (RWD) guidance, or Real World Evidence (RWE) concepts
• Experience working within a Quality Management System (QMS)
• Experience working with SmartSheets
• All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy
Benefits
• In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements).
• No matter where or when you begin a career with us, you’ll find a far-reaching choice of benefits and incentives.
Apply tot his job
Apply To this Job