Senior Associate, Strategic Planning & Operations
Amgen · Hyderabad · onsite · Posted 72d ago
Undisclosed3–6 yrsfulltimeSourced from
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About this role
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 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 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
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Skills
KanbanWritingAgileScrumenvironmentofficesciencefunctionalSharepoint Administrationpresentation skillsBiotechnologymanagementProject ManagementoperationsPMOanalyticalexcelSharepointMicrosoft TeamsPharmaceutical
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
About
Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
Industries
BiotechnologyBiotech & Life sciences
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