You will be taken to Amgen’s own careers page to apply. Job ID R-257583.
Job description
Career Category Regulatory Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
Key Responsibilities
Independently author routine to moderately complex regulatory documents, including: ICFs and ICF Amendments, PLPSs and PLPS Amendments, CSR sections (synoptic, abbreviated, and standard reports; pivotal CSRs with guidance/support), PLS, Protocol Amendments and Country-Specific Protocol Supplements, IB updates (minor/focused updates).
Manage document versions, reviewer comments, and approval workflows end-to-end for assigned documents.
Ensure assigned documents are scientifically accurate, internally consistent, and aligned with source data and program objectives.
Prepare documents that are QC-ready and inspection-ready, adhering to applicable guidance documents, SOPs, and regulatory requirements.
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Support audits and inspections by providing document history, supporting documentation, and justification/rationale as required.
Collaborate with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and efficiently incorporate feedback.
Participate in document-related meetings, as required.
Proactively escalate risks, scope changes, and timeline challenges to managers.
Track assigned deliverables and ensure adherence to agreed timelines.
Participate in internal training programs, knowledge-transfer sessions, and continuous process improvement initiatives.
Demonstrate consistent, on-time delivery of assigned deliverables.
Collaboration Skills
Cross-functional stakeholder management
Effective communication and presentation skills
Negotiation and conflict resolution
Strategic thinking and decision-making
Ownership and accountability
Project Management and Operational Skills
Timeline planning and execution
Managing multiple deliverables simultaneously
Risk identification and mitigation
Review coordination and comment resolution
Proficiency in document management systems, RIM tools, SharePoint, and document authoring platforms
Basic Qualifications
Master’s degree and 5 to 8 years of directly related experience
EQUAL OPPORTUNITY STATEMENT 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 with 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 an accommodation.
