Job Opportunities API

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 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 , t o join the   Cent e r 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   p rograms • 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 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 • Identif y   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 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 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 .