GRAAS Operations Manager - Data & Analytics

Let’s do this. Let’s change the world. In this vital role you will help deliver Amgen’s strategic approach towards Regulatory Affairs analytics, Data Standards and emerging Data Standard compliance. The role involves managing Data and Analytics resource in AIN, partnering with cross-functional stakeholders who utilize Regulatory and Master data across processes and systems. This role will manage the delivery of key analytics and reporting.

 

Roles & Responsibilities: 

Delivering quality and compliance in global regulatory data analytics services across processes and systems.

Aid alignment with international data standards to ensure compliance with Health Authority regulations for submission and registration.

Assist in delivering identified Regulatory Data and Analytics requirements.

Implement strategy aimed at alignment with new and existing Regulatory Data Standards, Analytics, and Reporting.

Deliver against defined standards to scale data and usage with repeatable processes to keep data up to date.

Leverage global regulations to support system and process simplification, automation and innovation.

Organize and present data in user friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance.

 

Required Knowledge and Skills: 

Strong knowledge of

Proven leadership in regulatory data and analytics and reporting

Proven experience of delivering data-centric processes and systems.

Strong Knowledge of managing structured and unstructured data

Demonstrated strength in change management and partner engagement

 

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 regulatory systems and data experience OR

Bachelor’s degree and 6 to 8 years of regulatory systems and data experience OR

Diploma and 10 to 12 years of regulatory systems and data experience

Preferred Qualifications:

Strong understanding of IDMP, Regulatory Affairs business complexity and process interdependencies

Experience with regulatory master data in Regulatory Affairs, Research, Development, Quality Management, or related area.

Demonstrated experience in leading impactful teams.

Proficiency in data visualization tools or packages, such as Tableau or Spotfire.

Proven and strong interaction with global collaborators

Experience with managing data strategy across a large enterprise

Expertise in team leadership and KPI deliverable

Experience in Regulatory Affairs.

 

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.

 

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