Deputy Archivist

Career Category Research Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Deputy Archivist What you will do Let’s do this. Let’s change the world. The Deputy Archivist at Amgen serves as a subject matter expert (SME) for GLP archiving. This role is accountable for ensuring the integrity, traceability, and availability of archived GLP data in accordance with applicable regulations, and internal Amgen requirements, and plays a critical role in inspection readiness across global regulatory authorities. Leads complex archiving strategies, drives inspection readiness initiatives, and influences cross-functional stakeholders to ensure the integrity, security, and accessibility of critical nonclinical study records. The role may serve as the backup GLP Archivist during regulatory inspections and internal audits. Serve as the GLP Archive SME, ensuring alignment with global regulations and Amgen quality standards/policies. Lead and oversee GLP archive operations, including intake, indexing, secure storage, retrieval, retention, and authorized destruction of records and specimens. Serve as backup GLP Archivist for all archive-related duties, including Research Satellite Archive and eArchive. Partner with Archive vendors to maintain precise archive inventories and material management. Develop and implement compliant archiving strategies to support evolving regulatory expectations and digital transformation initiatives Partner with Test Site Management, Principal Investigators, CRO Archivists, Quality, and other nonclinical teams to ensure lifecycle management of GLP records. Create, own, update, and maintain archive-related SOPs, work instructions, and training materials. Assess regulatory impact of changes to archiving processes and systems; provide risk-based recommendations to leadership. Ensure data integrity, confidentiality, and adherence to Amgen’s information governance and data protection standards. What we expect of you Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL) OR Bachelor’s degree and 4 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL) OR Associate’s degree and 8 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL) OR High school diploma / GED and 10 years of Experience working in healthcare regulated environments (eg FDA, OECD, LGL) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: A 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 Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, d Apply tot his job Apply To this Job