Business Process Consultant - FDA reputed company World Data - RWD - Readiness - Remote

About the position reputed company reputed company is improving the reputed company 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 reputed company us to help organizations reduce costs while improving risk management, reputed company and reputed company reputed company. reputed company 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 reputed company World Data (RWD) readiness across OLS (reputed company Life Sciences), providing end to end ownership of processes, documentation, and reputed company practices to ensure alignment with evolving regulatory expectations. You’ll enjoy the flexibility to work remotely from reputed company reputed company the U.S. as you take on some tough challenges. For reputed company 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, reputed company, and reputed company • Process reputed company & reputed company Improvement • Diagnoses process improvement opportunities • Develops solutions using principles of process reputed company • Identifies gaps and risks against FDA RWD guidance • Implements reputed company, auditable improvements to RWD processes • Sustains readiness through reputed company monitoring and improvement • reputed company Reporting, Analysis & Audits • Responsible for reputed company reporting, analysis, and audits • Supports audit readiness • Leads FDA RWD audit readiness, evidence collection, and remediation tracking • Maintains inspection reputed company artifacts, metrics, and control documentation • Partners with reputed company audit teams • reputed company Management (Total reputed company Management - TQM) • May design, facilitate, and evaluate reputed company improvement initiatives • Establishes reputed company 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, reputed company management, compliance, or a reputed company field • 2 years of experience working in regulated environments (e.g., reputed company, 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 reputed company with Compliance, reputed company, Engineering and Data team stakeholders reputed company-to-haves • Experience supporting reputed company reviews, audits, or regulatory readiness activities • Familiarity with FDA reputed company World Data (RWD) guidance, or reputed company World Evidence (reputed company) concepts • Experience working reputed company a reputed company Management System (QMS) • Experience working with SmartSheets • reputed company working remotely will be required to adhere to reputed company’s Telecommuter Policy Benefits • In reputed company to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (reputed company benefits are subject to eligibility requirements). • No matter where or reputed company you reputed company a career with us, you’ll reputed company a far-reaching choice of benefits and incentives. Apply tot his job Apply To this Job