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** , 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:**
+ Provide specialized support to a team of Observational Research Scientists specializing in real-world evidence projects in multiple regions
+ Provide comprehensive document requirement support, mainly to a team of Observational Research Scientists specializing in real-world evidence studies across the globe
+ Support adoption and integration of platforms such as Smartsheet, AI, Microsoft Teams, and Miro to enhance team collaboration and project tracking
+ Support strategic initiatives, including operational pilots, change management efforts that elevate CfOR’s organizational capabilities
+ Contribute to department/unit by ensuring quality of tasks/services provided
+ Communicate status and issues effectively to appropriate parties, both within CfOR and across Amgen
+ Assist leaders with study start-up and study close-out processes
+ Identify and implement process improvements through automated technology to increase efficiency, reduce cycle time and replace manual operations
+ Create, analyze, and maintain process flow diagrams to ensure efficient and effective operational workflows
+ Track and reconcile study milestones and deliverables, ensuring accurate data population in internal systems
+ Conduct regular meetings with study leads to discuss operational activities
+ Identify potential department/cross functional process improvement activities
+ 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
**Basic Qualifications:**
+ Bachelor’s degree and 6+ years of Scientific or Operations experience OR
+ Master’s degree and 4+ years of Scientific or Operations experience
**Preferred Qualifications/Skills:**
+ Minimum of 3 years of project management experience, with 2+ years in pharma/biotech within regulated, 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
