Description
Increasing demand for observational research (now commonly referred to as real-world evidence [RWE] from regulatory and reimbursement authorities makes observational research a key component of 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. CfOR scientists partner 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 are seeking a **Senior Associate, Strategic Planning & Operations** , to join the Center for Observational Research (CfOR). This role will work with other Amgen functional teams to oversee and drive execution of CfOR’s operational projects and non-interventional studies ensuring timely completion within budget and at the highest quality with compliance. This role requires strong project management capabilities combined with a growth mindset and openness to leveraging emerging AI tools to improve productivity and drive CfOR-wide initiatives.
**Key Responsibilities**
+ SupportCFOR team in **end-to-end operational workflows** to improve efficiency inCfORoperational processsuch as budgeting, contracting, compliance activities and PMO office.
+ Driving **AI-enabled operational transformation** to 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
+ **P** **roject management** **experience** including project planning, governance tracking, studies milestone management, risk/issue tracking, and stakeholder reporting
+ **SharePoint management** experience 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
**Project** **Management** **Office**
+ 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
**Complianc** **e** **& 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 of **project** **management** experience,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
