Amgen logo
AmgenPosted 1 month ago

Senior Associate, Strategic Planning & Operations

On-siteHyderabad, Telangana, India

Full TimeSenior LevelEnterprise

Job Summary

Oversee and drive execution of CfOR operational projects and non-interventional studies, ensuring timely completion within budget and at the highest quality with compliance. Manage end-to-end operational workflows to improve efficiency in budgeting, contracting, and PMO processes while monitoring study milestones, risks, and performance metrics. Lead AI-enabled operational transformation to enhance efficiency in compliance and decision-making across global programs. Provide specialized documentation support for global observational research studies and maintain SharePoint content governance for secure collaboration. Develop operational dashboards using Power BI and Excel to track resource utilization and key KPIs, delivering actionable insights to leadership. Apply Agile and hybrid project management methodologies to improve execution visibility and drive adoption of digital collaboration tools.

Required 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
  • application of technology/ AI knowledge expertise
  • advanced excel knowledge
  • dashboard creation for reporting
  • decision support
  • Minimum of 5 years of project management experience
  • +3 years in pharma/biotech and cross-functional environments
  • Hands-on experience with budgeting
  • vendor management
  • 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
  • applicable regulatory/compliance frameworks critical to clinical and commercial operations

Desired Qualifications

  • growth mindset
  • openness to leveraging emerging AI tools to improve productivity and drive CfOR-wide initiatives
  • strong project management capabilities
  • 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
  • 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
  • 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
  • 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
  • Understanding compliance / governance activities, across eTMF, regukatory, inspection readiness, and submission processes, ensuring documentation completeness, traceability, and adherence to SOPs and regulatory requirements
  • Managed financial operations including PO processing, invoice verification, and expense tracking using SAP/Ariba/Anaplan
  • Supported budget planning and resource management across programs
  • Minimum of 5 years of project management experience
  • +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

Hiring someone like this?

Get your role in front of qualified candidates on Sorce.

Get started

Apply to this job in one click with Sorce

Apply on Sorce