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