R&D Supplier Governance Manager
3 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
R&D Supplier Governance ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will support the governance and deployment of emerging new technologies within the Decentralized Clinical Trials (DCT), Digital Health, and Devices space.
The Manager will be pivotal for the successful deployment of these novel technologies and modalities across our portfolio including but not limited to connected devices, wearables/sensors, mobile health applications, decentralized platforms, digital recruitment, and novel site models (e.g., integrated research organizations). This role will be directly responsible for ensuring that our suppliers deliver effective services and technology solutions and will work across various internal stakeholders including but not limited to Global Strategic Sourcing, Clinical Program Operations, Compliance, GxP Compliance, Site Management, Digital Health and Innovation, Digital Medicine, Clinical Systems and Applications, Representation in Clinical Research).
Lead supplier evaluation, qualification, & remediation activities for R&D clinical trial suppliers. Serve as a subject matter expert and provide technical/operational guidance to study teams during vendor set-up. Oversee clinical trial DCT, Digital Health, and Device suppliers and own supplier functional management team governance activities (e.g., regular meetings, governance documentation, issue management/tracking, etc.). Collaborate with study and site management teams on operational implementation of digital and decentralized solutions. Liaise cross-functionally and with suppliers to develop and track appropriate performance metrics. Ensure regulatory inspection readiness and participating in audits. Developing strong collaborative relationships with internal partners to support and respond to business needs. Collate and maintain best practices/ lessons learned to ensure implementation on future studies. Maintain supplier governance documentation and ensure proper filing. May also support other categories as needed. WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications. Basic Qualifications: Doctorate degreeOr Masters degree and 2 years of biotech/pharma-related business operations/supplier management experienceOr Bachelors degree and 4 years of biotech/pharma-related business operations/supplier management experienceOr Associate degree and 8 years of biotech/pharma-related business operations/supplier management experienceOr High School Diploma/GED and 10 years of biotech/pharma-related business operations/supplier management experience Preferred Qualifications: BS/BA/BSc in the sciences or RN Minimum 5 years' experience in life sciences or medically related field, including 3 years' experience biopharmaceutical clinical research experience (clinical research experience acquired by working on clinical trials at a biotech, pharmaceutical, CRO or technical services supplier) Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, medical device companies, DCT service providers, digital recruitment, integrated research organizations, real world data aggregation etc.) Knowledge and technical experience with DCT and Digital Health technologies, and Devices and their application to clinical trials Work experience in monitoring, quality control and auditing practices Prior experience with vendor set-up activities for above mentioned services is a plus (e.g., device design review, user acceptance testing) Excellent project management and organizational skills Ability to work independently and as part of a team Excellent communication and interpersonal skills Familiarity and Knowledge with/of clinical trial execution, supplier management, Good Clinical Practice (GCP), FDA regulations and guidelines, including 21 CFR Part 11, ISO 13485, FDA 510(k) premarket notification, CE marking, and Quality Management System processes ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen does not have an application deadline for this position ; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.-
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