Amgen

Manager

• Implement and manage descriptive epidemiologic studies characterizing disease incidence and prevalence in the US, EU, Asia, and emerging market countries
• Implement and manage research projects analyzing medical claims, electronic health records, and prospective observational cohort studies
• Provide safety research support across the Amgen product life cycle
• Support development of risk management plans
• Drive pharmacovigilance studies
• Conduct literature reviews
• Prepare research reports and scientific manuscripts
• Stay current on observational research and drug development developments
• Promote awareness, understanding, and use of observational research methods
• Communicate significant scientific information to varied audiences
• Contribute as first or contributing author to peer-reviewed papers, scientific congress abstracts, or internal reports

Observational Research Manager – Inflammation / Rare Disease

• Partner closely with Global Safety Officers, Clinical Development, Regulatory Affairs, and other cross-functional stakeholders to develop and execute product safety strategies across the product lifecycle
• Lead signal detection, validation, prioritization, evaluation, and management using multiple safety data sources and methodologies
• Conduct scientific and medical evaluation of adverse events and emerging safety concerns from clinical trials, post-marketing surveillance, literature, and external data sources
• Perform complex safety analyses and communicate evidence-based recommendations supporting product safety decisions
• Integrate safety databases, clinical studies, literature, epidemiology, and external sources to assess potential safety signals
• Support benefit-risk evaluations informing product development, regulatory submissions, labeling updates, and lifecycle management
• Lead or contribute to planning, preparation, authoring, review, and submission of aggregate safety reports, including PBRERs/PSURs, DSURs, Safety Assessment Reports, and regulatory safety responses
• Provide strategic safety input into clinical protocols, statistical analysis plans, safety analysis plans, investigator brochures, and clinical study reports
• Review and recommend improvements to safety data presentations, including tables, figures, and listings
• Represent Global Patient Safety within safety governance and cross-functional teams
• Present safety analyses, emerging signals, benefit-risk assessments, and Global Safety Team recommendations to governance committees and decision-making bodies
• Contribute to global risk management strategies, Risk Management Plans, risk minimization activities, and regulatory documentation
• Support regulatory submissions, health authority interactions, product launches, and lifecycle management initiatives
• Support regulatory inspections, audits, pharmacovigilance compliance activities, and continuous inspection readiness
• Undertake activities delegated by the Qualified Person for Pharmacovigilance as described within the Pharmacovigilance System Master File
• Ensure compliance with global pharmacovigilance regulations, GVP guidance, ICH requirements, and internal Amgen procedures
• Lead or support initiatives improving pharmacovigilance processes, methodologies, quality, compliance, and operational efficiency
• Participate in implementation of new safety processes, technologies, and methodologies
• Provide scientific leadership and mentorship to junior pharmacovigilance scientists and project team members
• Contribute to safety strategy discussions supporting oncology, immunology, inflammation, rare disease, and biologic development programs
• Perform other duties related to the position as assigned by management or described in applicable procedures

Global Pharmacovigilance Scientist, Manager – Oncology

Compliance

• Assist the Regional Regulatory Lead with regional regulatory activities
• Provide and maintain IND/MA documentation support, including annual reports and amendments
• Create and maintain product regulatory history documents through RIM and archive regulatory documents and agency communications
• Review regional components of the Global Regulatory Strategic Plan and provide input to operational deliverables
• Conduct regulatory research supporting regulatory strategy and target product label development
• Support regulatory compliance and submission compliance
• Prepare supportive documentation for regulatory deliverables, including regulatory landscapes and research
• Coordinate collection of functional documents for regulatory applications
• Participate in GRT activities and assist with meeting management, agendas, and minutes
• Assist with responses to regulatory agency questions
• Coordinate quality control of regulatory documentation
• Author routine regulatory correspondence, including annual reports and investigator packages
• Prepare regulatory packages and cross-reference letters for investigator-initiated studies
• Complete regulatory forms supporting agency communications, including FDA Form 1571
• Support process improvement initiatives, standards development, metrics, and template maintenance
• Respond to GRT requests and communicate relevant issues
• Support development and execution of GRT goals

Senior Associate – Regulatory Affairs

Representative

• Serve as the primary customer contact for Amgen products
• Provide clinical product knowledge and communicate clinical benefits to medical professionals
• Implement marketing strategy and promote Amgen products under the District Manager
• Deliver branded sales messages and conduct planned programs
• Schedule and follow up on medical educational programs
• Achieve or exceed territory sales targets through in-person and virtual engagement
• Develop and manage customer account relationships
• Customize customer interactions based on customer needs
• Ensure product access and resolve or triage reimbursement issues
• Maintain product contracts
• Provide feedback on marketing strategy and analyze sales activity and territory performance
• Develop territory plans with the District Manager
• Share best practices and collaborate with colleagues
• Build product brands while keeping patient impact at the forefront
• Uphold Amgen’s values, ethical standards, quality, teamwork, communication, and accountability

Senior Specialty Representative – Primary Care

• Strengthen and advance Amgen’s R&D Quality Management System (QMS)
• Provide quality support for Amgen programs at all stages of products in clinical development
• Input audit responses into QMS
• Input site inspection data into the Inspection Management System
• Work with deviation owners to ensure timely development and closure of CAPAs
• Ensure timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee
• Collaborate with Clinical Study Teams to facilitate communication
• Prepare weekly metric reports for the General Medicine team, highlighting overdue items and supporting timely closure
• Assess the effectiveness of metric reports and optimize them with the data quality analytics team
• Facilitate Rare Disease team meetings, including agenda and presentation preparation
• Maintain Decision & Action logs and Q&A logs, and follow up with action owners until resolution
• Support inspection readiness activities
• Provide quality oversight of small clinical programs
• Leverage AI tools and technologies to streamline workflows, automate processes, and support data-driven decision-making
• Develop lessons learned and best practices documentation
• Collaborate with other Amgen R&D Quality functions
• Maintain the Rare Disease SharePoint site and Teams channels

Senior Associate, Quality Compliance

General

• Expand Amgen’s computational toolbox for assessing the safety of small molecule drug candidates and potentially other modalities
• Work with computational scientists and nonclinical safety experts on early drug-discovery safety predictions
• Identify, curate, and compare external and internal data, including chemical structures, assay results, and exposure information
• Develop and evaluate structural alerts, analogue-based read-across, machine learning, and models integrating experimental results with other safety evidence
• Evaluate model performance on relevant compounds
• Document context of use, uncertainty, applicability, and limitations
• Collaborate with computational scientists, medicinal chemists, and toxicologists to guide compound prioritization and follow-up experiments
• Present results and deliver reproducible analyses, documented model prototypes, and development recommendations
• Provide mechanisms for retraining as additional data is generated over time

Grad Co-op – Computational Safety Modeling for Small Molecules

Operations

• Provide operational coordination and executional support across the U.S. Neurology Medical Marketing organization
• Convert strategic priorities into project plans, operating rhythms, trackers, and team preparation
• Maintain integrated calendars, workback plans, action logs, status trackers, and core documentation
• Coordinate planning, status, preparation, and debrief meetings; prepare materials and track actions
• Support budget tracking, purchase-order and invoice coordination, forecasting, and reconciliation
• Support congress kickoffs, project plans, readiness meetings, deliverable tracking, submissions, communications, vendor coordination, and closeout activities
• Coordinate speaker training operations and maintain Speaker Bureau and program-readiness trackers
• Support HCP education and engagement programs, including project plans, materials routing, stakeholder communications, vendor logistics, budget tracking, and closeout
• Provide planning and logistics support for advisory boards and insight-generation activities
• Organize field-insight submissions, track follow-up questions, and prepare summaries and readout materials
• Maintain insight repositories, source materials, and action trackers
• Complete stretch assignments such as process improvements, dashboards, content workflows, or components of congress, P2P, and insight initiatives
• Build working knowledge of UPLIZNA, gMG, NMOSD, customer segments, Medical Marketing roles, promotional review requirements, and regulated operating standards
• Collaborate with cross-functional teams, external agencies, HCP Operations, Finance, Procurement, Medical Affairs, Sales, Regulatory, Legal, and Global partners
• Manage sensitive information, budgets, deadlines, and partner interactions while maintaining compliance

Senior Associate – Operations, Programs – Neurology

Medical Science Liaison

• Act as the primary scientific/clinical resource to Opinion Leaders, Population Health Decision Makers, and other healthcare providers
• Execute Amgen Medical function and product strategy as led by MSL Leadership to provide accurate information and improve patient outcomes
• Conduct peer-to-peer activities with obesity and related-conditions Opinion Leaders, community healthcare providers, and Population Health Decision Makers
• Engage with clinical investigators and sites in support of the obesity pipeline
• Communicate clinical, outcomes, and economic data to Population Health Decision Makers within assigned IDNs and institutions
• Connect external and internal stakeholders to amplify Amgen’s reach and patient access
• Conduct in-depth scientific exchange consistent with MSL compliance standards
• Support Amgen-sponsored research and potentially serve as a study lead
• Liaise with potential investigators in non-sponsored clinical research
• Provide field observations and insights to internal stakeholders to inform Amgen strategies
• Lead and support congress activities
• Support speaker training and ensure speakers are updated on new data
• Lead and/or participate in project teams supporting MSL strategies and tactics
• Partner compliantly across Amgen field roles to create a coordinated One Amgen experience
• Mentor other MSLs as designated by MSL leadership
• Complete administrative responsibilities and training
• Report to the Obesity MSL Lead

Senior Medical Science Liaison – Obesity

• Support and/or lead Amgen Financial and Operational process audits in the U.S.
• Conduct audits with Corporate Audit teams covering Anti-Bribery/Anti-Corruption, Healthcare Compliance, Privacy and Third-Party risks
• Support improvement projects covering all aspects of internal audit activity
• Perform the Annual Audit Plan approved by the Audit Committee
• Assist Senior Managers and Corporate Audit staff in providing independent, objective assurance and consulting services
• Evaluate whether Corporate Audit processes, document management systems, controls and governance are adequate and functioning appropriately
• Interact with Amgen senior and mid-level management during engagements
• Exercise sound judgment and initiative in handling significant business issues
• Assist on special projects as needed
• Discharge responsibilities consistently with The Institute of Internal Auditors’ Code of Ethics, International Standards for the Professional Practice of Internal Auditing and Statement of Responsibilities
• Travel minimally, less than 10% expected

Corporate Audit Manager

Sales

• Serve as liaison to customers by providing clinical knowledge of Amgen products to medical professionals
• Track the progress of marketing messages and programs
• Provide feedback to district teams on marketing, allocating, monitoring, and leveraging internal and external resources, including discretionary spend
• Manage district teams to maximize performance and achieve or exceed sales and budget targets
• Screen, interview, and hire candidates
• Ensure compliance with training
• Coach and counsel individuals to prepare them for future development
• Conduct annual and ongoing performance reviews and competency assessments
• Communicate and coordinate with district and cross-functional teams, including Marketing, Finance, and other business units
• Share best practices with direct reports and peers
• Coordinate and/or participate in cluster teams
• Conduct district sales meetings to guide districts
• Develop local Opinion Leader relationships to achieve aligned objectives

District Sales Manager – Oncology

Full-stack Engineer

• Lead systems engineering and device development activities for dry powder inhaler combination products
• Translate user and patient needs and product objectives into system and device requirements, interface definitions, design outputs, verification strategies, and integrated drug-device-capsule solutions
• Own and drive Design History File and Design and Development Plan activities for the DPI device constituent
• Lead needs and requirements engineering, system and subsystem interface definition, design reviews, design verification strategy, configuration management, and change control
• Apply EDDO / delivery-output thinking to control device outputs important to dose delivery, aerosolization, usability, and combination-product performance
• Maintain traceability from needs and requirements through risk controls, design outputs, verification, and supporting evidence
• Lead technical integration of supplier-provided DPI platforms and evidence
• Assess supplier design, verification, manufacturing, and master-file evidence; identify gaps and bridging needs
• Provide technical oversight of device suppliers, including design changes, investigations, verification evidence, and lifecycle support
• Partner with combination product SMEs and drug product, analytical, regulatory, quality, manufacturing, clinical, human factors, and other development teams
• Lead drug-device-capsule integration and manage critical interfaces among the dry-powder drug product, capsule, inhaler, and user
• Coordinate cross-functional stakeholders to support technical decisions, submissions, issue resolution, and lifecycle changes

Senior Engineer – Combination Product Inhalation Device Lead

• Serve as the single accountable leader for Amgen’s global GMP/GDP audit organization and predictive compliance intelligence capability
• Establish strategic direction, operating model, technical standards, and multiyear roadmap
• Lead the global risk-based GMP/GDP audit strategy and master audit schedule
• Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure
• Evaluate manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities
• Determine when emerging risks require expanded audit scope, targeted assessments, for-cause audits, multisite evaluation, or executive escalation
• Build the predictive compliance intelligence capability, including data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance measures
• Integrate audit data, inspection outcomes, regulatory trends, supplier performance, deviations, CAPAs, complaints, recalls, and other quality signals into an enterprise risk view
• Develop predictive models, dashboards, early-warning indicators, and risk scenarios
• Identify systemic risks and recurring failure mechanisms
• Lead auditor technical capability strategy, competency requirements, qualification standards, continuing education, and subject-matter expertise access
• Oversee AI-enabled audit and compliance intelligence tools while maintaining human judgment, Quality accountability, audit independence, and objective evidence
• Advise the enterprise AI governance organization on GMP/GDP matters
• Provide senior leadership with actionable insight on emerging compliance risks and recommended interventions
• Lead and develop a multidisciplinary global audit and compliance intelligence organization
• Own the audit continuous-improvement roadmap and measures of audit effectiveness
• Partner with RRIR, ILM, and External Affairs on inspection readiness, inspection outcomes, regulatory trends, and compliance priorities

Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

• Manage defined accounts within a specified geographic region for Patient Access and Reimbursement
• Support the Respiratory business unit by executing the collaborative territory strategic plan
• Ensure understanding of the reimbursement process, field reimbursement services, and patient support programs
• Resolve patient-level reimbursement issues using knowledge and experience with patient health information (PHI)
• Act as an extension of the HUB, providing live one-on-one coverage support
• Assist from physician order to reimbursement, including payer prior authorization and appeals/denials requirements and forms
• Review patient-specific information when sites request assistance with coverage challenges
• Educate and update healthcare providers on private and public payer coverage changes affecting product access
• Coordinate access and reimbursement issues with relevant partners, including the HUB
• Explain product coverage under Commercial, Medicare, and Medicaid benefit designs
• Serve as a payer expert for the defined geography and communicate payer changes to stakeholders
• Provide office education on formulary coverage, utilization management, insurance forms and procedures, benefits investigation, prior authorization, appeals, and claims resolution
• Educate offices using approved materials
• Review patient insurance benefit options and alternate funding/financial assistance programs
• Collaborate with other departments to resolve reimbursement issues
• Attend customer appointments three days per week in the assigned geography

Field Reimbursement Manager

• Develop and execute the global regulatory product strategy
• Lead Global Regulatory Teams (GRTs)
• Represent Regulatory on the product team and key commercialization governance bodies
• Develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan
• Identify and communicate regulatory risks
• Develop registration strategies and plans for regulatory approval and product labeling
• Provide regulatory direction in development of the core data sheet
• Lead planning and implementation of global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes
• Ensure consistency of evidence-based global product communication and regulatory submission documents
• Monitor and assess relevant global regulations, guidance, and the regulatory environment
• Assess and incorporate regulatory mechanisms such as FIH studies, Orphan Drug, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans
• Communicate regulatory strategies throughout the organization
• Lead core regulatory and cross-functional teams for effective regulatory agency communications
• Attend key regulatory agency meetings affecting global product strategy
• Represent Amgen Regulatory on external partnership teams at the product level

Global Regulatory Affairs Director – Inflammation and Rare Disease

Human Resources

• Serve as a trusted strategic advisor to senior leaders within Amgen's Finance organization
• Partner with the Senior Vice President and Finance leadership team to align people strategies with business objectives and workforce plans
• Translate business strategy into actionable talent and organizational initiatives
• Lead organizational design, operating model evolution, workforce planning, and change management initiatives
• Support leaders through restructuring, role optimization, capability building, and business transformation
• Assess organizational health and improve effectiveness, agility, and employee experience
• Drive talent review, succession planning, and leadership development processes
• Identify, develop, and retain high-potential talent and critical capabilities
• Foster a high-performance culture and strengthen employee engagement, retention, development, and inclusion
• Leverage workforce analytics, talent data, and organizational insights for strategic decisions
• Identify talent trends, risks, opportunities, attrition, capability gaps, and organizational performance issues
• Partner with Talent Acquisition and business leaders to attract top talent
• Drive strategic workforce planning and support internal mobility and career development
• Collaborate across HR and business functions on integrated people solutions and enterprise-wide HR initiatives
• Mentor and develop HR colleagues