Job Description
Career CategorySafetyJob DescriptionWhat you will doLet’s do this. Let’s change the world. In this vital role you will help ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners and regulatory authorities.Roles & Responsibilities:Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the whole study lifecycle. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical Trial submission dossier through close cross-functional collaboration.Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables.Be responsible for the Quality control (QC) of data and documents before CTIS upload.Be responsible for the cross-functional coordination of Requests for Information (RFI) process from initial reviewing and triaging, through to technical document preparation, submission in CTIS and archive in the relevant internal system.Be the critical technical coordinator for Clinical Trial Notifications through CTIS, ensuring accurate and timely input of data and archive into the relevant internal system.Assist with the definition, development, and implementation of processes to meet evolving CTIS needs.Raise, advise and resolve any issues that may impact submission process or timelines within CTIS.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.Basic Qualifications:Bachelor’s degree and 0 to 3 years of directly related experience ORDiploma and 4 to 7 years of directly related experiencePreferred Qualifications:Practical experience with Veeva VaultFamiliarity with global regulatory processes and standardsAbility to quickly learn new software, regulations and processesProactive, innovative problem solver and well-organized teammateWhat you can expect of usAs 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.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com.
