1074 Amgen Technology Pvt Ltd.

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><h2> Career Category</h2>Clinical Development<h2/><h2> Job Description</h2>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 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. 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:<ul><li>Provide specialized support to a team of Observational Research Scientists specializing in real-world evidence projects in multiple regions</li><li>Provide comprehensive document requirement support, mainly to a team of Observational Research Scientists specializing in real-world evidence studies across the globe</li><li>Support adoption and integration of platforms such as Smartsheet, AI, Microsoft Teams, and Miro to enhance team collaboration and project tracking</li><li>Support strategic initiatives, including operational pilots, change management efforts that elevate CfOR’s organizational capabilities</li><li>Contribute to department/unit by ensuring quality of tasks/services provided​</li><li>Communicate status and issues effectively to appropriate parties, both within CfOR and across Amgen</li><li>Assist leaders with study start-up and study close-out processes​</li><li>Identify and implement process improvements through automated technology to increase efficiency, reduce cycle time and replace manual operations</li><li>Create, analyze, and maintain process flow diagrams to ensure efficient and effective operational workflows</li><li>Track and reconcile study milestones and deliverables, ensuring accurate data population in internal systems</li><li>Conduct regular meetings with study leads to discuss operational activities</li><li>Identify potential department/cross functional process improvement activities</li><li>Execute financial transactions, including purchase order processing, invoice verification, payment processing, and engaging with other functions to help plan and manage resource expenses, using Anaplan, Ariba or SAP software</li></ul> Basic Qualifications:<ul><li>Bachelor’s degree and 6+ years of Scientific or Operations experience OR</li><li>Master’s degree and 4+ years of Scientific or Operations experience</li></ul> Preferred Qualifications/Skills: <ul><li>Minimum of 3 years of project management experience, with 2+ years in pharma/biotech within regulated, cross-functional environments</li><li>Hands-on experience with budgeting, vendor management, and regulated document management systems</li><li>Demonstrates autonomy and reliability in managing tasks and contributing to team goals</li><li>Highly organized, with the ability to prioritize and deliver on projects independently or collaboratively</li><li>Quick learner with strong analytical skills and adaptability to new tools and concepts</li><li>Effective communicator with strong written, verbal, and presentation abilities</li><li>Builds positive relationships and fosters collaboration with a proactive, “can-do” attitude</li><li>Demonstrated proficiency & adaptability with related software tools (ChatGPT, Copilot, Smartsheet, Miro, SharePoint, MS Teams, Office 365, etc.)</li><li>Familiarity with drug commercialization & business practices</li><li>Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations</li></ul>.</body></html>

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