Amgen

Compliance

• Lead the strategy, governance, development, and lifecycle management of Amgen’s Global Corporate Compliance Policies
• Ensure alignment and consistency across global and U.S. compliance policies
• Serve as the primary bridge between policy content and enterprise compliance training
• Drive simplification, modernization, and effective governance of policy content
• Establish and maintain a scalable policy governance framework
• Partner with various teams to ensure policies reflect evolving regulatory requirements
• Leverage technology solutions to enhance policy drafting and review efficiency
• Monitor regulatory developments and industry benchmarks
• Support internal audits and regulatory inquiries related to policy documentation and training alignment
• Drive adoption of advanced capabilities including AI enabled search and workflow automation
• Track and report on policy lifecycle metrics
• Serve as a strategic advisor to leadership on policy risk areas and content priorities
• Mentor and guide team members supporting policy and training activities.

Senior Manager, Global and U.S. Healthcare Compliance Policy

Operations

• Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
• Support the submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors
• Support interactions with business partners (license partners) and vendors for all case intake and processing activities.
• Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures.
• Ensuring vendor compliance with approved processes and training requirements.
• Audit & external inspection support
• Manage multiple business partner relationships for case management
• Monitor compliance regarding regulatory submissions and/or contractual wording for data exchange
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Pharmacovigilance Operations Manager

Manager

• This critical role will focus on maintaining and building relationships with external Opinion Leaders and large medical centers involved in vasculitis, and the broader Rheumatology and Nephrology provider landscape.
• The Thought Leader Liaison (TLL) Sr. Manager will report into the Director of Professional and Marketplace Engagement and will join the National team of Rare Disease Inflammation Thought Leader Liaisons in the Inflammation Business Unit.
• The TLL will be a critical member of the Brand Team and will coordinate closely with field teams.
• The TLL will be responsible for the following, but not limited to: OL / Strategic Customer Development and Management Identify, cultivate, and maintain professional relationships with established and up-and-coming regional Opinion Leaders in ANCA Vasculitis (Rheumatology / Nephrology / other specialties diagnosing and managing vasculitis)
• Support deep engagement of key customers (ex. Navigating IDNs / Centers of Excellence, Professional Organizations, Foundations/Patient Organizations)
• Manage OL Speaker bureau relationships including supporting speaker training, compliance, and product theater speaker management
• Manage regional speaker bureau, including providing speaker recommendations
• Identify, map, and manage relationships with key national Vasculitis Centers and other large treatment facilities (includes the detailed mapping of referral patterns, key relationships, and influencers)
• Coordinate and leading all one-to-one exchanges between brand team and KOLs across key initiatives and events Congress / Key Event Management Attend and manage brand activity at key regional and national inflammation conferences (may encompass Rheumatology, Nephrology, Pulmonology), including managing product theaters, and other ancillary brand activities
• Manage overall regional sponsorship budget, including working with organizations to secure sponsorships, and owning regional congress plan
• Coordinate executive meetings with OLs at national conferences
• Complete all necessary conference and speaker contract requirements in a timely manner
• Coordinate with marketing to ensure all congress materials are delivered on time
• Coordinate with sales, marketing, and medical affairs Work cross functionally to drive and develop aligned external engagement strategies across multiple cross functional teams including medical, training, marketing, and sales
• Coordinate closely with the sales team to ensure alignment with conference OL engagement plan as well as other OL/account engagement
• Provide customer and market insights back to the marketing team and provide input into P2P development, advisory boards, and strategy
• Partner with the HCP Marketing team to develop advisory board strategy, content, advisory recommendations, and attend advisory boards as appropriate
• Provide insights summary from key congresses to the marketing team
• Drive key initiatives Leading peer-to-peer marketing initiatives such as advisory boards, speaker bureau & product theater content development Shaping team content development needs include disease state Participate in strategic discussions with brand team

Senior Manager – Rare Disease Vasculitis Thought Leader Liaison

• Manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit in partnership with a CRO in a fully outsourced business model
• Lead CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery
• Manage biosimilars CDM activities and program(s), including system infrastructure and integration and maintenance of SharePoint site permissions and content
• Input into group goals and objectives
• Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies
• Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs
• Ensuring delivery of quality clinical trial data, within agreed upon timelines
• Ensuring CDM processes/systems meet regulatory and business requirements
• Assist with CRO contracts and budgets

Senior Manager, Clinical Data Management

Pricing Analyst

• Play a critical role in leading and guiding the overall analytics strategy for TEPEZZA in the U.S.
• Manage and mentor a high-performing team, delivering actionable insights that support brand strategy development and measurement
• Drive data-driven decision-making across key business functions
• Oversee the development and delivery of robust secondary analytics, including National and Subnational insights, a KPI measurement framework, and other strategic recommendations
• Identify risks, opportunities, and key growth drivers to help unlock barriers, optimize efficiencies, and guide business strategies toward accelerated growth.

Director, Commercial Analytics

Systems Engineer

• Lead large capital project and product teams by fostering Agile delivery while operating within GMP manufacturing environments.
• Partner with site and global stakeholders to prioritize demand, manage backlogs, and balance local needs with global strategy.
• Accountable for financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets.
• Drive global standards, templates, and best practices for large operations technology project and product design, deployment, lifecycle management, and support to enable scalability and operational excellence.
• Ensure solution delivery meets GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness requirements.
• Lead cross-functional collaboration between site and corporate Operations, Quality, IT, OT, Automation, Platform Owners, and external system integrators.
• Own the global operations technology roadmap, including upgrades, standardization, harmonization, and site deployments, aligned with business and regulatory requirements.
• Mentor and coach junior project managers or Scrum Masters.
• Present status updates and progress to senior leadership at various governance meetings.

Principal Manufacturing Systems Engineer

Marketing

• Leading the planning and implementation of all media and media partnerships, critical to commercial success of Amgen’s Oncology brands
• Supporting both consumer (DTC) and professionally-targeted (HCP) media strategies, investments and measurement
• Developing and evangelizing an in-depth understanding of the core targets, and extensive knowledge of the DTC and HCP media landscapes, both traditional and emerging
• Reporting into the Associate Director, US Media of Rare Disease and partnering heavily with internal and external cross-functional partners and be responsible for leading and managing our media agencies
• Supporting the development and implementation of innovative, powerful multi-channel media plans, including strategic partnerships with critical media outlets
• Leading development of brand media briefs in partnership with brand teams
• Managing all elements of brand media plans, including leading the agency to develop annual and in-year plans, that meets agreed objectives, tracking weekly, monthly and quarterly critical metrics and ensuring delivery on budget
• Working across the RDBU portfolio, in partnership with the GCC Media Team, brand teams and agency, to optimize the portfolio media strategy, targeting and tactical brand plans to drive synergies, effectiveness and efficiencies
• Leading strategic development and realization of media partnerships, improving return on investment, value and performance
• Uncovering insights to drive continuous optimization of media plans based on metrics, and ensure findings are shared and applied across brands
• Leadership of media agency to hold them accountable to the highest standards of performance
• In partnership with CD&A, developing and tracking metrics for media mix and media effectiveness, while linking to the KPIs and broader success metrics of the brand
• Being the brand liaison and key support to Corporate advocacy, Patient advocacy and SciComm
• Implementing test and learns to support marketing innovation in media
• Enhancing processes to improve the way we operate with our media agency and deliver reporting, financials, and best practices for the brands
• Driving media training initiatives to help upskill within the organization
• Onboarding new media partners on the Amgen processes
• Supporting key GCC Media Enterprise projects and contributing to the future evolution of GCC Media
• Leading project management initiatives on new media assignments
• Attending external and internal training/conferences and sharing insights with GCC Team

Senior Media Marketing Manager, Rare Disease

QA Engineer

• Serve as the quality lead and subject matter expert for critical global suppliers of GMP raw materials
• Own the end-to-end quality oversight of assigned suppliers—from onboarding through ongoing performance monitoring to disengagement
• Act as the primary quality contact for internal stakeholders, supporting issue resolution, supplier strategy, and cross-functional initiatives
• Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards
• Review and approve quality documentation
• Participate in and/or lead supplier audits and collaborate with internal and external partners
• Prepare Amgen sites and suppliers for audits and inspections
• Identify and mitigate risks at the supplier and/or escalate to management
• Drive audit commitments to completion.
• Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions.
• Take the lead and/or participate in cross-functional initiatives and continuous improvement projects.

Senior QA Manager – External Supply Quality, Supplier Quality Management

• Ensure appropriate quality oversight of suppliers in line with global regulations, defines quality requirements for suppliers and monitors performance
• Monitors and assigns quality status and, if required, determines remediation actions and additional oversight needed, including technical site visits
• Maintains key quality performance indicators for suppliers of responsibility
• Review and approval of quality records such as; Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EV’s
• Manage supplier audits to completion
• Act as point of contact for Amgen sites to resolve concerns and support projects regarding secondary packaging materials and suppliers
• Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
• Identify and mitigate risks at supplier site and raise to management as appropriate
• Onboard and offboard suppliers and/or manufacturing location as needed
• Lead departmental improvement projects regarding continuous improvement and automation

Senior Quality Assurance Manager

Data Scientist

• Collaborate with business partners including commercial insights and analytics, brand teams, sales operations, data teams, external vendor partners, media agencies, service owners, and IS partners to create solutions and insights to solve challenging business problems across multiple therapeutic areas and commercial functions.
• Apply deep technical expertise to manipulate large messy datasets, write high-quality code, and adapt complicated machine learning models to the problems at-hand.
• Use and develop data science, machine learning, and artificial intelligence capabilities across Amgen’s commercial organization.
• Transform business, medical, or scientific questions into analytical ones and map out solutions, delivery, and impact.
• Identify business needs and propose potential analytical approaches for solutions.
• Build high-performance algorithms, prototypes, predictive models, and proof of concepts using Python or R with reliable performance, interpretability, and action-ability.
• Communicate cross-functionally with stakeholders to develop appropriate methodology to answer specific business questions.
• Help further build the team by contributing ideas and standard methodologies and keeping abreast of developments in industry and academia.
• Communicate effectively and influence a diverse set of technical, scientific, medical, and business constituents at the functional and executive levels.
• Create powerful stories in PowerPoint, with knowledge of MS Office Suite (Excel and PowerPoint).
• Assure compliance with regulatory, security, and privacy requirements as it relates to data assets.

Account Manager

• represent TEPEZZA to physicians and health care professionals
• establish product sales
• perform total territory account management
• Provide account management support to accounts within a specific geography
• Develops a comprehensive and effective territory business plan
• Promotes TEPEZZA within approved labeling in a comprehensive, fair and ethical manner
• Addresses issues related to access, pull-through, and reimbursement
• Develops strong customer relationships by understanding the customer’s needs and goals
• Consistently meets or exceeds corporate sales goals
• Communicates territory activity in an accurate and timely manner
• Drive product demand among targets through education on disease state and product information
• Provides feedback to sales and business unit leadership
• Adheres to the Company’s compliance policies and guidelines
• Coordinate between accounts and relevant Amgen field teams
• Educate healthcare professionals and office staff on site of care options
• Attend medical congresses and society meetings as needed
• Manage efforts within assigned promotional and operational budget
• Maximize use of approved resources to achieve territory and account level goals
• Complete administrative duties in an accurate and timely fashion
• Function as a contributing member of a high-performance team.

Account Manager – Specialty Account Manager, TEPEZZA

• Manage contracting strategy and execution for assigned national payer accounts, aligned to brand and business objectives.
• Own the contract document lifecycle across multiple workstreams, including version control and clear, proactive status updates to internal partners.
• Drive timely deliverables by making clear recommendations, flagging and resolving issues early, and keeping actions moving to minimize rework.
• Draft term sheets, RFP responses, amendments, and related contract language to support negotiations and renewals, accurately reflecting pricing strategy design, rebates, and discount structures.
• Facilitate document review meetings and ensure partners have the right context on document status, history, and decisions needed to move forward.
• Project manage planned and ad hoc initiatives within Contract Development and U.S. Value & Access, coordinating inputs and timelines across stakeholders.
• Compile and produce contract documentation to support internal/external audits and litigation, ensuring completeness and traceability.
• Partner with the CLM system team to support process and system improvements that strengthen contracting execution.

Payer Contracting Manager

• Join Amgen’s Center for Observational Research (CfOR) organization
• Support CfOR by setting goals with epidemiologists and laying out strategy to deliver on those goals
• Coordinate with a functional service provider-based team of contract statistical programmers
• Identify potential efficiency improvements and propose solutions
• Ensure the analysis and presentation of biomedical data is accurate and complete
• Adhere to Amgen policies, SOPs, and other controlled documents
• Review and approve key study-related documents produced by other functions
• Write, and/or review and approve programming plans and analytic dataset specifications
• Represent the programming function in multidisciplinary team meetings
• Contribute to the continuous improvement of programming, CfOR, and R&D processes
• Participate in the development and review of CfOR Policies, SOPs and other controlled documents
• Support and mentor junior programmers

Biostatistical Programming Manager

• Serve as the senior escalation authority for complex informed consent and biospecimen governance matters, providing final interpretation of participant intent and partnering with Institutional Review Boards and Ethics Committees to enable compliant and efficient study start-up
• Establish and maintain the enterprise governance framework for informed consent templates related to biospecimen collection, retention, and reuse, ensuring alignment across clinical programs and evolving global regulatory expectations
• Lead and develop a multi-layered operating model across internal staff and FSP partners, ensuring appropriate segmentation of transactional, rules-based, and judgment-driven work while driving overall operational performance
• Identify systemic gaps across the biospecimen lifecycle and lead cross-functional initiatives to implement scalable solutions that improve cost efficiency, turnaround time, and governance quality
• Own the strategic direction of biobank operations, including inventory optimization, long-term storage and disposition strategy, and advancement of key transformation initiatives aligned with the future-state operating model
• Set vendor and supplier strategy for long-term storage and biobank services, including selection, performance oversight, and alignment with enterprise cost and capacity planning goals
• Provide executive oversight of biospecimen transfer activities supporting in-licensing and out-licensing, ensuring risk mitigation, compliance, and seamless integration with broader R&D transactions
• Ensure inspection readiness and governance oversight for nonclinical biospecimen management under GLP, reinforcing quality systems and regulatory compliance expectations
• Define and drive capability-building strategy across the biobank function, including training frameworks, escalation pathways, and role clarity to support the evolving governance and program leadership model

Senior Manager, Biobank

• Serve as a resource on patient access and reimbursement for infused and specialty therapies
• Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes
• Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims
• Provide education regarding coding and billing considerations relevant to therapy access
• Develop relationships with patients and caregivers through phone, virtual, and in-person engagement
• Secure written or electronic patient HIPAA authorization within assigned geography
• Assess individual patient needs and provide education and resources that support access to therapy
• Educate patients on coverage considerations and the steps required to obtain prior authorization
• Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate
• Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes
• Provide information regarding common prior authorization requirements, coding considerations, and billing practices
• Support healthcare providers and infusion centers in navigating reimbursement questions related to patient cases
• Investigate patient access challenges before and after infusion
• Support physician offices and sites of care in reviewing denied claims and identifying potential next steps
• Escalate complex or systemic reimbursement issues to appropriate internal stakeholders
• Partner with internal stakeholders including Market Access, Medical Affairs, Advocacy, Case Managers, and Site of Care teams to support patient access initiatives
• Coordinate with internal and external partners to ensure appropriate resources are available to support patient access
• Share field insights regarding payer policies and reimbursement challenges
• Adhere to company policies, compliance guidance, and applicable to federal, state, and local regulations
• Ensure activities align with HIPAA privacy requirements and internal compliance guidelines
• Report adverse events and product complaints through established pharmacovigilance processes
• Maintain accurate documentation of activities and interactions in Amgen’s internal system