• Directs the planning, preparation, writing and review of portions of aggregate reports • Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products • Supports and provides oversight to staff with regards to safety in clinical trials • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents • Review of AEs/SAEs from clinical trials as needed • Review standard design of tables, figures, and listings for safety data from clinical studies • Participate in development of safety-related data collection forms for clinical studies • Participate in study team meetings as requested or needed • Signal detection, evaluation, and management • Perform data analysis to evaluate safety signals and write up analysis results • Documents work as required in the safety information management system • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body • Assist GSO in the development of risk management strategy and activities • Provides contents for risk management plans • Develop or update strategy and content for regional risk management plans • Assist GSOs to oversee risk minimization activities including tracking of activities as needed • Evaluate risk minimization activity • Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO • Support activities related to new drug applications and other regulatory filings • Assist GSO in developing a strategy for safety-related regulatory activities • Provide safety contents for filings • Inspection Readiness • Undertake activities delegated by the QPPV as detailed in the PV System Master File • Maintain a state of inspection readiness.

• Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate • Lead a group of Rare Disease and/or other therapeutic area products • Accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas • Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally • Plan and monitor progress of projects and address issues accordingly • Support GSP Functional Service Provider (FSP) relationship and oversight • Ensure the product goals can be met via the FSP staff • Provide GSP product level input to developing and managing resource plans and budgets for GSP • Efficiently and effectively monitor and utilize assigned staff at product level according to priorities • Lead and/or participate in departmental process improvement initiatives and cross-functional working groups • Assist in study and system audits and inspections by internal and external bodies • Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally • Provide hands-on support to the assigned product areas as required • Provide coaching and mentoring to staff • Provide input into career development plans for all staff on assigned projects.

• Establish and manage program governance structures, operating models, and decision-making frameworks. • Lead program management activities across multiple interconnected workstreams. • Ensure alignment of program objectives with enterprise strategy and business priorities. • Identify interdependencies, critical path and risks while working to resolve issues. • Drive accountability across program teams and stakeholders to deliver outcomes. • Serve as a trusted advisor to executive sponsors and senior leadership. • Prepare and present program updates to senior executives and steering committees. • Translate complex program information into concise executive-level communications. • Escalate critical issues and facilitate timely decision-making. • Oversee integrated program plans, milestones, deliverables, and dependencies. • Ensure effective coordination across business units and functions. • Monitor progress against objectives and proactively address execution risks. • Lead cross-functional problem-solving efforts to remove barriers to success. • Establish and maintain enterprise-level risk and issue management processes. • Drive mitigation planning and resolution of complex cross-functional challenges. • Identify and manage interdependencies across programs and business initiatives. • Ensure timely escalation of material risks and decisions. • Develop executive dashboards and program health reporting. • Provide data-driven insights and recommendations to leadership. • Monitor program performance against scope, schedule and budget. • Support realization tracking and post-implementation reviews. • Enhance PMO methodologies, governance standards, and best practices. • Drive consistency in program execution across the enterprise. • Mentor junior PMO staff and project managers.

• Serve as a Registered Nurse on the Maine team supporting family caregivers • Conduct initial in-home visits prior to the start of caregiving services • Review and implement the Authorized Plan of Care provided by the state’s Assessing Services Agency • Provide on-site supervision to caregivers at least monthly for the first three months of each family’s enrollment in the program • Maintain accurate clinical documentation and ensure EVV (Electronic Visit Verification) compliance • Continue initial and supervisory home visits for new and existing patients • Train and evaluate caregiver competency and conduct annual performance reviews • Monitor patient health status and coordinate with the service coordination agencies / physicians regarding significant changes • Ensure ongoing compliance with documentation standards and EVV requirements