Senior Associate Strategic Planning & Operations

**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**, 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  .