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
- Support CFOR team in end-to-end operational workflows to improve efficiency in CfOR operational process such as budgeting, contracting, compliance activities and PMO office.
- Driving AI-enabled operational transformation to enhance efficiency in compliance process, budget tracking, and decision-making across global CfOR programs
- 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 management experience in content governance to enable effective collaboration and efficient document control.
Operational Excellence & Process Optimization:
- Support end-to-end workflows and process maps to improve efficiency in CFOR operational process
- Drive execution of operational processes by monitoring budgets, contracts, study milestones, risks, and performance metrics while ensuring data accuracy, timely reporting, and adherence to regulatory, compliance and 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
- Identify automation opportunities to reduce manual effort and standardize workflows
- Creating dashboards of operational processes
- Drove adoption and migration of 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, ensuring timely delivery, quality, and alignment with business priorities.
- Ability to apply Agile, Scrum, Kanban, or hybrid project management methodologies to improve execution, collaboration, and operational efficiency and improve project visibility and execution tracking.
Data, Reporting & Dashboarding:
- Developed and maintained operational dashboards and reports (Power BI/Excel/Smartsheet) to track study performance, resource utilization, 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 degree with 7+ years of Scientific or Operations experience OR
- Master's degree and 5+ years of Scientific or Operations experience
- Pharma/ Healthcare degree with application of technology/ AI knowledge expertise, advanced excel knowledge, dashboard creation for reporting, and decision support.
Preferred Qualifications/Skills:
- Minimum of 5 years of project management experience, with +3 years in pharma/biotech and cross-functional environments
- Hands-on experience with budgeting, 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 prioritize and 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 with drug commercialization & business practices
- Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations
