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Senior Manager - Regulatory Data And Analytics

Amgen
Amgen
14-18 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Amgen’s Mission of Serving Patients

At Amgen, we’re united by a shared mission: to serve patients living with serious illnesses. Since our founding in 1980, we’ve led the way in biotechnology, focusing on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Diseases. Each year, we touch millions of lives by researching, manufacturing, and delivering innovative medicines that help people live longer, fuller, and happier lives.

Our award-winning culture is rooted in collaboration, innovation, and science. If you have a passion for challenges and opportunities, you’ll thrive as part of the Amgen team. Join us, and together, let’s transform the lives of patients while transforming your career.


Senior Manager – Regulatory Data and Analytics

What You Will Do
As a Senior Manager, you will be responsible for leading and building a successful team focused on global regulatory data analytics. You will drive operational excellence, innovation, and technical compliance for Amgen’s regulatory submissions and information management.

Key responsibilities include:

  • Leading the Regulatory Data and Analytics Team: Build and lead a team focused on delivering global regulatory data services, ensuring compliance with international data standards.
  • Strategy Development: Lead the development and implementation of Regulatory Data Standards, Analytics, and Reporting.
  • Cross-Functional Collaboration: Partner with the Digital Technology and Innovation team to develop data strategies, ensuring global visibility and insights.
  • Data Insight & Automation: Increase data insight to simplify decision-making and streamline processes through automation.
  • Data Visualization: Organize and present data in user-friendly, graphical, and interactive summaries to provide insights on performance and improve business results.
  • Regulatory Compliance: Ensure data flows and submissions meet health authority regulations while maintaining accurate and up-to-date metadata.

What We Expect of You
We are seeking a leader with experience in regulatory data systems, a strong background in data strategy, and proven leadership in driving analytics and reporting within a global organization.

Basic Qualifications

  • Doctorate degree and 2 years of regulatory systems experience, or
  • Master’s degree and 8 to 10 years of regulatory systems experience, or
  • Bachelor’s degree and 10 to 14 years of regulatory systems experience, or
  • Associate’s degree and 14 to 18 years of regulatory systems experience.
  • Advanced knowledge of Veeva Vault.
  • Proven leadership in regulatory data and analytics, data-centric processes, and systems.
  • Strong understanding of handling structured and unstructured data.
  • Change management and customer engagement experience.

Preferred Qualifications

  • 5+ years of experience in Regulatory Affairs.
  • Expertise in delivering data strategy across large enterprises.
  • Understanding of IDMP, Regulatory Affairs business complexities, and process interdependencies.
  • Experience with regulatory master data in areas such as Research, Development, or Quality Management.
  • Proficiency in data visualization tools such as Tableau or Spotfire.
  • Strong global partner interaction experience.

What You Can Expect of Us

At Amgen, we are committed to your professional and personal growth. In addition to a competitive salary, we offer a comprehensive benefits package that includes:

  • Health Benefits: Medical, dental, and vision coverage.
  • Retirement Plans: Generous contributions to help you plan for the future.
  • Work-Life Balance: Flexible work models and generous time-off policies.
  • Career Development: Continuous learning and growth opportunities.
  • Incentives: Stock-based long-term incentives and annual bonuses.

Join Us.

If you’re ready to make an impact and drive the future of regulatory data and analytics at Amgen, apply now for a career that defies imagination.

careers.amgen.com

Amgen is an Equal Opportunity Employer. We value diversity and are committed to providing accommodations for individuals with disabilities during the application and interview process.