Associate Director, Healthcare Compliance Operations, Europe
PharmaBiotechRegulatory AffairsQuality Assuranceheormedicalemacroraveinform
Job description
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.The Opportunity:
The Associate Director, Healthcare Compliance Operations, Europe will serve as the Healthcare Compliance Operations lead for the Europe region and will be responsible for developing, implementing, and maintaining the compliance infrastructure, systems, processes, data, and operational capabilities necessary to support Revolution Medicines’ growing European organization and commercialization activities. This includes establishing scalable and effective Compliance processes across key areas of the program, including transactions with healthcare professionals (HCPs), healthcare organizations (HCOs), and other members of the Healthcare Community, as well as other Europe region Compliance processes and controls required to support the Company’s continued growth and commercialization. This individual will play a key role in implementing and supporting Compliance technology solutions, developing Compliance analytics, key performance indicators (KPIs) and key risk indicators (KRIs), supporting European transparency reporting activities, and driving continuous improvement of the Company’s European Healthcare Compliance operating model.
Reporting to the Director, Compliance, this individual will be a key member of the Healthcare Compliance Operations team and will partner closely with European Medical Affairs, Commercial, Market Access, Finance, Legal, Procurement, Information Technology, and other functions to translate global Healthcare Compliance standards into practical, scalable Europe region processes that address applicable European and local-country requirements.
This position is based in Basel, Switzerland.
Europe Healthcare Compliance Operations Lead the development, implementation, and ongoing enhancement of the Healthcare Compliance Operations model for Europe, aligned with the Company’s Healthcare Compliance Operations framework globally. Translate global Compliance standards and requirements into scalable Europe region processes that appropriately address European and applicable local-country regulatory, industry code, and business requirements. Provide practical, risk-based Compliance guidance regarding Healthcare Community transactions, consistent with assigned responsibilities and the Compliance function’s global operating model. Establish and maintain effective Europe region processes, procedures, controls, tools, and documentation supporting Healthcare Compliance activities. Identify opportunities to harmonize, simplify, automate, and improve Compliance-related processes while maintaining appropriate controls. Analyze operational activity to identify trends, recurring issues, potential Compliance risks, and opportunities for enhanced controls, training, or process improvement. Compliance Systems & Technology Support the Europe region implementation, rollout, and ongoing management of Compliance-related systems and technology solutions. Serve as the Europe region Compliance Operations lead for systems supporting HCP consulting and speaking engagements, congress sponsorships, HCP sponsorships, HCP expenses and meals, and other Healthcare Compliance activities. Support the implementation and effective use of technology solutions supporting European transparency reporting. Partner with Information Technology, system vendors, and business stakeholders to define Europe region requirements, configure workflows, test solutions, support implementation, and drive user adoption. Ensure European business and regulatory requirements are appropriately incorporated into global systems and technology solutions. Develop and maintain appropriate Europe region system governance, documentation, controls, training, and user support. Identify opportunities to leverage technology and automation to improve the efficiency, consistency, scalability, and effectiveness of European Compliance Operations. Support ongoing system enhancements and lifecycle management as European business requirements and Compliance processes evolve. European Transparency & Disclosure Support the Company’s European Healthcare Compliance transparency and disclosure program. Provide Europe region support for data capture and management processes related to applicable European and country-specific transparency reporting and disclosure requirements. Partner with Finance, Medical Affairs, Commercial, Information Technology, vendors, and other data owners to facilitate accurate and timely capture of reportable transfers of value. Support Europe region implementation, testing, adoption, and ongoing use of the Company’s transparency reporting technology and associated processes. Assist with data validation, reconciliation, remediation, and other activities necessary to support data quality and reporting accuracy. Coordinate with European business stakeholders to resolve Europe region data issues and support implementation of processes necessary to meet applicable transparency and disclosure requirements. Support communications, training, and change management associated with European transparency reporting processes. Leverage transparency and HCP/HCO spend information, as appropriate, to support Europe region Compliance analytics, monitoring, and risk identification. Training, Change Management & Continuous Improvement Develop and deliver training and communications supporting European Healthcare Compliance systems, processes, and operational requirements. Lead change management and adoption efforts associated with implementation of new Compliance systems and processes. Develop practical tools, guidance, job aids, and other resources to help business stakeholders understand and comply with Healthcare Compliance operational requirements. Gather stakeholder feedback and operational data to continuously improve Europe region processes and user experience. Identify opportunities for harmonization and share European learnings and best practices across regions. Promote operational excellence and continuous improvement as the European organization and Healthcare Compliance program mature. Audit, Monitoring & Inspection Readiness Maintain appropriate documentation and evidence supporting European Healthcare Compliance processes and operational controls. Support Compliance monitoring activities, internal audits, Compliance assessments, and external inspections as needed. Coordinate remediation and corrective actions arising from monitoring, audit, or operational findings. Monitor implementation and effectiveness of remediation activities and identify opportunities for broader process improvements. Support development and enhancement of operational controls based on monitoring results, data analytics, identified risks, and evolving business activities Required Skills, Experience and Education: Bachelor’s degree or equivalent university-level qualification. Advanced degree or professional qualification in law, compliance, business, life sciences, or a related discipline preferred. 8+ years of relevant experience in healthcare compliance, compliance operations, ethics and compliance, commercial operations
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