Senior Associate, Strategic Planning & Operations at Amgen · Hyderabad

Senior Associate, Strategic Planning & Operations Location: India - Hyderabad Career Category Strategy and Innovation Job Description Increasing demand for observational research (now commonly referred to as real-world evidence [RWE] from regulatory and reimbursement authorities makes observational research a keycomponentof drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle. CfORscientistspartner with internal stakeholders and industry experts to design, conduct, interpret and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines. We areseeking aSenior Associate, Strategic Planning & Operations, to join theCenter for Observational Research (CfOR).This role will work with other Amgen functional teamsto oversee and drive execution ofCfOR’soperational projects and non-interventional studies ensuringtimelycompletion within budget and at the highest qualitywith compliance. This role requires strong project management capabilities combined with a growth mindset and openness toleveragingemerging AI tools to improve productivity and drive CfOR-wide initiatives. Key Responsibilities SupportCFOR team in end-to-end operational workflowsto improve efficiency inCfORoperational processsuch as budgeting, contracting, compliance activities and PMO office. DrivingAI-enabled operational transformationto enhance efficiencyincomplianceprocess, budget tracking, and decision-making across globalCfORprograms Provide specialized operational and documentation support for global observational research (RWE) studies, partnering with cross-functional scientific teams Project management experience including project planning, governance tracking, studies milestone management, risk/issue tracking, and stakeholder reporting SharePoint managementexperience incontent governance to enable effective collaboration and efficient document control. Operational Excellence & Process Optimization: Supportend-to-endworkflows and process maps to improve efficiencyinCFOR operational process Drive execution of operational processes by monitoring budgets, contracts, study milestones, risks, and performance metrics while ensuring data accuracy,timelyreporting, and adherence to regulatory, complianceand organizational requirements. Ensured quality, compliance, and alignment with global operational standards Strong experience in SharePoint management, including site administration, document libraries, permission management, and content governance to enable secure collaboration and efficient document control AI & Digital Enablement: Applied generative AI tools to improve productivity in documentation and operational processes Identifyautomation opportunities to reduce manual effort and standardize workflows Creatingdashboardsof operational processes Drove adoptionand migrationof digital tools (Smartsheet,MS tools,Teams, SharePoint, Miro, lucid) for collaboration and tracking ProjectManagementOffice Demonstrated experience in PMO practices, including project planning, governance tracking, milestone management, RAID tracking, and stakeholder reporting, ensuringtimelydelivery, quality, and alignment with business priorities. Ability to apply Agile, Scrum, Kanban, or hybrid project management methodologies to improve execution, collaboration, and operational efficiency andimprove project visibility and execution tracking. Data, Reporting & Dashboarding: Developed andmaintainedoperational dashboards and reports (Power BI/Excel/Smartsheet) to track study performance, resourceutilization, and key KPIs Delivered actionable insights through data analysis and reporting to support leadership decision-making Compliance& Governance: Understanding compliance / governance activities, across eTMF,regukatory, inspection readiness, and submission processes, ensuring documentation completeness, traceability, and adherence to SOPs and regulatory requirements. Financial & Resource Management: Managed financial operations including PO processing, invoice verification, and expense tracking using SAP/Ariba/Anaplan Supported budget planning and resource management across programs Basic Qualifications: Bachelor’s degreewith7+years of Scientific or Operations experience OR Master’s degreeand5+years ofScientific or Operations experience Pharma/ Healthcare degree with application of technology/ AI knowledge expertise, advanced excel knowledge,dashboardcreation for reporting, and decision support. Preferred Qualifications/Skills: Minimum of5years ofprojectmanagementexperience,with+3years in pharma/biotechandcross-functional environments Hands-onexperiencewithbudgeting, vendor management,and regulated document management systems Demonstrates autonomy and reliability in managing tasks and contributing to team goals Highly organized, with the ability to prioritizeand deliver on projects independently or collaboratively Quick learner with strong analytical skills and adaptability to new tools and concepts Effective communicator with strong written, verbal, and presentation abilities Builds positive relationships and fosters collaboration with a proactive, “can-do” attitude Demonstrated proficiency & adaptability with related software tools (ChatGPT, Copilot,Smartsheet, Miro, SharePoint, MS Teams, Office 365, etc.) Familiarity withdrug commercialization & business practices Comprehensive understanding of Good Clinical Practices (GCP),FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations .