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 , 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  

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