Job Description

Career Category SafetyJoin Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas xe2x80x93Oncology, Inflammation, General Medicine, and Rare Diseasexe2x80x93 we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Manager - Regulatory Data ManagementWhat you will doThe Global Submission and Information Management (GSIM) team brings strategic technical expertise to drive operational excellence, innovation, and technical compliance for Amgen's global regulatory submission and information management. Ensures smooth, compliant data flows among functional areas, external partners, and regulatory authorities while designing and implementing process improvements, digital technologies, data standards, and organizational change management to achieve business results.The Senior Manager of Regulatory Data Management will help shape and implement the system based framework for regulatory data management at Amgen. The role involves leading the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners who use the company Regulatory Information Management system. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance.Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system.Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement.Ensure the team meets key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency.Drive continuous improvement initiatives to enhance service delivery and operational processes.Minimize potential errors by establishing policies & processes for data usage.Supervise the provision of high-quality data processing, system utilisation and data management services to global clients.Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices.Stay abreast of regulatory developments and ensure the team is follows all relevant regulations and standards.What we expect of youBasic Qualifications:Doctorate degree and 2 years of regulatory systems experience ORMasters degree and 8 to 10 years of regulatory systems experience ORBachelors degree and 10 to 14 years of regulatory systems experience ORDiploma and 14 to 18 years of regulatory systems experience ORAdvanced knowledge of Veeva Vault RIMProven leadership in regulatory data managementHands-on ability to work on data-centric processes and systems.Strong Knowledge of handling structured and unstructured dataDemonstrated excellence in change management and key customer engagement.Preferred Qualifications:Experience with delivering compliance assurance within a large companyExperience with large-scale enterprise systems in the Biotech/Pharmaceutical industry.5 years of proven experience in regulatory operations, submission management.Excellent understanding of Regulatory Affairs business complexity and process interdependenciesExperience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area.Demonstrated experience in building and leading successful teams.Sharp learning agility and analytical thinkingProven and advanced interaction with global key customersWhat 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, well 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.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided 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 accommodation..

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