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 functional 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 with compliance. This role requires solid 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 programs
* Provide specialized operational and documentation support for global
observational research (RWE) studies, partnering with cross-functional
scientific teams
* Project management experience including project planning, governance
tracking, studies milestone management, risk/issue tracking, and stakeholder
reporting