Senior Associate Data Management

• Responsible for maintaining data within the Regulatory Information Management (RIM) system
• Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
• Serve as a Data Management SME within cross-functional collaborative initiatives
• Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
• Provide support on creating, running and analysing reports for data streamline projects
• Develop and deliver training materials and presentations to a global audience
• Manage the protocol Amendment New Investigator (PANI) submission updates
• Manage 1572 forms for FDA submission
• Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods
• Adhere to Amgen processes, policies, guidelines, SOPs and training documentations

• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• In depth understanding of the Veeva Vault system
• Good written and verbal communication skills
• Detail oriented
• Independent time management and prioritization skills
• Work efficiently with little support and minimal to no supervision
• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
• Critical thinking skills
• Appropriate software skills as required
• Strong analytical and problem solving, communication and presentation skills
• Good understanding of business complexity and project inter-dependencies
• Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus
• Fluent in English, both in oral and written communication
• Experience in supporting projects / improvement initiatives
• Master’s degree and 5-8 years of directly related experience OR Bachelor’s degree and 6-9 years of directly related experience

• Advanced knowledge of Veeva Vault RIM
• Be open to working in a dynamic environment embracing change as a constant and adopting new technologies
• Working in global teams and matrix organizations
• Able to follow through on tasks and motivate others to meet deadlines
• Practical experience with CTIS system

Competitive and comprehensive Total Rewards Plans aligned with local industry standards