Let’s do this. Let’s change the world. In this vital role you will have a strong background in data management, regulatory affairs, and people management.
Roles & Responsibilities:
Provide support through line-management and as an individual contributor to ensure the execution of Data Management team objectives related to data quality. consistency and compliance
Monitor data quality/health, including collaboration with other internal functions to maintain accuracy of key registrational data and ensure that appropriate metrics are provided to measure success
Ensure timely updates to the Regulatory Submissions and Document Information Management System, as necessary
Manage requests from the Regulatory Intake System to deliver effective data management of complex data issues within the Regulatory Submissions and Document Information Management System
Day to day issue and resource management
Hire, develop and mentor team members to take on additional responsibilities and advance in their career path
Create and contribute to the development of processes, policies, guidelines, SOPs and training documentation.
What we expect of you
We 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:
Doctorate degree OR
Master’s degree and 4 to 6 years of directly related experience OR
Bachelor’s degree and 6 to 8 years of directly related experience OR
Diploma and 10 to 12 years of directly related experience
Preferred Qualifications:
Strong interpersonal and teamwork skills, with the ability to interact with data owners and users.
Team leadership experience within a data management context.
Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
Familiarity with global data standards.
Life Sciences, Biotech or pharmaceutical industry experience preferred.
Proven Veeva Vault knowledge.
Preferred Knowledge and Skills:
Advanced knowledge of Veeva Vault,
Familiarity with global regulatory processes and standards.
Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.
What you can expect of us
As 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 now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com