Job Description
Career CategoryClinicalJob DescriptionABOUT AMGENAmgen 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.What you will doPrepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential informationWork closely with cross-functional stakeholders to define redaction strategy, lead review and approval, ensure submission readiness, and hand off for timely submission or postingEnsure consistent quality across documents, ensure submission readiness, and hand off for timely submission or postingCommunicate with team members to resolve problems and escalate issuesRecord and maintain written redaction strategy for the study and productSupport trend analysis and process improvementWhat we expect of youMaster’s degree and 1 to 3 years of relevant experience ORBachelor’s degree and 3 to 5 years of relevant experience ORDiploma and 7 to 9 years of relevant experienceMinimum of 2 years experience in preparing regulatory documents for public disclosureFamiliarity with clinical research and clinical regulatory documentsKnowledge of clinical trial disclosure regulations, guidelines, and best practicesBasic Qualifications:Experience understanding and interpreting data/information and its practical applicationSelf-motivated with developed skills in multi-tasking, attention to detail, and follow-throughAbility to follow controlled processesExcellent spoken and written EnglishAbility to negotiate and influenceProject management skills, including ability to prioritize work in order to meet required deadlinesProblem solving abilityEQUAL OPPORTUNITY STATEMENTAmgen 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..
