• Lead and develop a set of managers running multi-disciplinary teams of project managers, implementation consultants, and technical staff across healthcare product lines • Set team strategy for project planning, staffing, and resource allocation across concurrent NetMenu and Quickcharge engagements • Ensure the team delivers professional services to healthcare clients, meeting established goals for utilization, revenue, and customer satisfaction • Guide implementation teams through the complexity of clinical environments, including EHR integrations (e.g., Epic/HL7), diet order workflows, and healthcare payment systems • Serve as a mentor and escalation point internally and externally; step into a client-facing role for strategic accounts to ensure satisfaction • Partner with Sales, Solution Engineering, and Client Management to ensure successful sales and implementations, where expectations are properly set around delivery timelines, scope, and readiness • Establish and manage third-party partnerships to supplement core staff during peak periods • Drive process improvement and efficiency gains across the team’s delivery model, with particular attention to the regulatory and patient safety demands of healthcare environments

• Provide required physician supervision for nurse practitioners in accordance with state regulations in Georgia • Conduct quarterly (at minimum) virtual meetings with supervised nurse practitioners to: • Review clinical cases • Provide guidance and mentorship • Ensure adherence to clinical protocols and standards of care • Perform periodic chart reviews and quality assurance checks • Be available on an as-needed basis for clinical consultation • Collaborate with clinical leadership to support: • Ongoing quality improvement initiatives • Protocol development and updates • Compliance with regulatory and payer requirements • Maintain appropriate documentation of supervisory activities as required by the state

Role Description As a member of the Regulatory Affairs organization, you will play a critical role in advancing innovative oncology therapies from development through registration and commercialization, helping bring transformative medicines to patients worldwide. The Associate Director, Regulatory Affairs Japan will serve as the regulatory lead for assigned development programs and products in Japan. This individual will be responsible for developing and executing regulatory strategies to support clinical development, registration, and lifecycle management activities. The role will represent Japan Regulatory Affairs on global project teams, contribute to PMDA interactions, and provide strategic regulatory guidance to support successful development and commercialization activities in Japan. Key Responsibilities - Regulatory Strategy Leadership - Lead regulatory activities for assigned programs and products in Japan. - Develop and execute regulatory strategies supporting clinical development, registration, and lifecycle management. - Conduct regulatory assessments and provide recommendations for development programs. - Identify regulatory risks and develop mitigation plans. - Provide regulatory guidance to cross-functional teams. - Health Authority Leadership - Lead PMDA consultations and routine regulatory interactions with appropriate management support. - Prepare briefing packages, meeting materials, and responses to health authority inquiries. - Lead or support J-NDA submissions and post-approval activities. - Ensure alignment of Japanese regulatory requirements with global development plans. - Global and Cross-Functional Collaboration - Represent Japan Regulatory Affairs on global project teams. - Collaborate with Clinical Development, Clinical Operations, Medical Affairs, Safety, CMC, Quality, and Medical Writing functions. - Contribute to project decision-making and regulatory planning. - Vendor and CRO Management - Manage regulatory consultants, vendors, and CRO partners supporting Japan activities. - Monitor timelines, deliverables, budgets, and quality of outsourced work. - People Leadership - Mentor junior regulatory colleagues and contribute to team development. - May provide supervisory responsibilities for contractors or junior staff. Qualifications - Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline; advanced degree preferred. - Typically 8+ years of pharmaceutical or biotechnology industry experience, including significant Regulatory Affairs experience. - Experience supporting regulatory strategy for clinical development and registration programs. - Strong knowledge of Japanese pharmaceutical regulations, PMDA processes, and ICH guidelines. - Excellent communication and collaboration skills. Preferred Skills - Oncology drug development experience. - PMDA consultation experience. - Experience supporting NDA/J-NDA submissions. - Experience working on global development programs. - Experience managing vendors or CROs. Leveling Considerations - Independently leads regulatory activities for assigned programs. - Provides strategic regulatory input and manages external partners. - Leads PMDA interactions with appropriate support.

Role Description The Director, Neurology Operations reports to the Senior Vice President, Neurology Operations, and is focused on driving the execution of the Neurology Business Unit’s (NBU) operational strategies and tactics. - Provide leadership and direction for day-to-day operations, in collaboration with the Senior Vice President, Neurology Operations focused on business unit transformation, growth, performance improvement and overall operational execution. - Lead the development and maintenance of advanced analytical tools, KPI dashboards, and performance reporting in partnership with IT, Data Warehouse, and Analytics teams, ensuring data integrity, standardization, and HIPAA compliance. - Lead the enhancements of clinical payroll and compensation systems, ensuring accuracy, transparency, and scalability through integration of data architecture and operational workflows. - Responsible for driving processes and monitoring KPIs related to turnaround times for internal requests on launch capacity and timing for late-stage growth opportunities coordinating with the Business Development Department and leading up to official “hand-off to launch” processes. - In coordination with the Senior Vice President, Neurology Operations, design and implement scalable, repeatable processes that incorporate operational, financial, and pricing considerations to support sustainable growth inclusive of new program offerings and operation readiness that fosters their success. - Support BU Leadership by partnering with Finance on forecast modeling and revenue realization tracking; support business unit leadership on Monthly Operational Reviews and key executive presentations. - Identify data quality risks, reporting gaps, and process inefficiencies early & support mitigation strategies. - Partner with Clinical Provisioning teams to enhance scheduling optimization and automation within the TIQ-Scheduler suite in Salesforce. - Provide direct supervision of staff, including assignment of work tasks, coaching and general performance management. - Coaches, develops and mentors direct reports with an emphasis on building career paths for professional growth. - Administer progressive discipline, including corrective action, when necessary, to ensure high levels of job performance and compliance with company policy. - Conduct formal performance appraisals for all direct reports and develops action plans for continued development and performance improvement. - Manage payroll activities for direct reports to include timekeeping, approval for time off requests, and other administrative functions. - Other duties as assigned. Qualifications - Bachelor’s degree in business administration, healthcare administration or related field. - At least 7 years of relevant work experience, in a healthcare environment, including operational leadership experience. - Advanced excel and analytics skills, including data visualization tools. - Proficiency with Microsoft Office programs. - Proficient interpersonal communication skills and the ability to exercise empathy when working with hospital partners, and physicians and patients. - Excellent organizational and time management skills. - Demonstrate an understanding of standard clinical procedures, laws and regulations. - Ability to work independently, but function as part of a team. - Desire to work in a high-growth, fast-paced environment. - Ability to operate with both precision and vision, driving scalable processes. - Ability to thrive in high growth, fast-paced organization and 100% Remote based environment. - Must be able to remain in a stationary position 50% of the time. - Occasional travel for meetings and collaboration. Benefits - 100% Remote Work. - Health Insurance (Medical, Dental, Vision). - Comprehensive benefits — health, dental, vision, life, and 401(k). - Flexible vacation and wellness days — we value performance and balance. - Culture of ownership, transparency, and results — where the best ideas rise. - Directly impact patient access nationwide.