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 products 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 CfORs operational projects and non-interventional studies ensuring timely completion within budget and at the highest quality with compliance . This role requires robust 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 managementexperience 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:

- Bachelors degree with 7 + years of Scientific or Operations experience OR

- Masters 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

📌 Senior Associate, Strategic Planning & Operations (Hyderabad)
🏢 Amgen
📍 Hyderabad