Associate GRAAS Operations

les.

• 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 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:

• Bachelor's degree and 0 to 3 years of directly related experience OR

• Diploma and 4 to 7 years of directly related experience

Preferred Qualifications:

• Practical experience with Veeva Vault

• Familiarity with global regulatory processes and standards

• Ability to quickly learn new software, regulations and processes

• Proactive, innovative problem solver and well-organized teammate

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

.