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SENIOR MANAGER – Amgen Internship Thousand Oaks

    Website Amgen

    Position Title: SENIOR MANAGER

    Company: Amgen

    Location: Thousand Oaks, CA, USA

    Job Description:

    Let’s do this. Let’s change the world. In this vital role you will provide strategic leadership for Regulatory Affairs Analytics, Data Standards (XEVMPD/IDMP) and emerging Data Standard compliance requirements.

    Responsibilities:

    • Ensure compliance with international data standards to ensure compliance with Health Authority regulations for submission and registration.
    • Collaborate cross-functionally internally and externally with Global Regulatory Affairs and Strategy (GRAAS) to identify Regulatory Data and Analytics requirements.
    • Lead Strategy development and implementation for new and existing Regulatory Data Standards, Analytics, and Reporting.
    • Partner with Digital Technology and Innovation (DTI) Team to develop multi- year Data Standards, Management, and Analytics to increase Regulatory Data Visibility and insights.
    • Increase data visibility to make it easier for staff to quickly and confidently find the right data for their business decisions.
    • Minimize potential errors by establishing policies & processes for data usage.

    Requirements:

    • Set standards to scale data and usage with repeatable processes to keep (meta) data up to date.
    • Leverage global regulation data 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.
    • Own the implementation of EU Clinical Trial Submissions for GRAAS.
    • Sharp learning agility and analytical thinking
    • Veeva Vault Knowledge
    • Organizational Change Management to adopt new processes and practice
    • Team Leadership, Coaching, and Mentoring.
    •  Customer-Centric
    • Vendor Management
    • Communication and relationship building.
    • Hands-on ability to work on data analysis and reporting
    • Strong Knowledge of managing structured and unstructured data
    • Demonstrated excellence in project and change management and stakeholder engagement
    • Excellent understanding of Regulatory Affairs business complexity and project interdependencies

    To apply for this job please visit careers.amgen.com.


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