Instagram
youtube
Facebook

Senior Manager - Regulatory Data And Analytics

14-18 years
Not Disclosed
10 Dec. 3, 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, feeling like part of something bigger is more than just a feeling—it’s our purpose. Our shared mission—to serve patients battling serious illnesses—is at the heart of everything we do.

Since 1980, we’ve been trailblazers in the biotech world, confronting some of the toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we make a difference in the lives of millions of patients annually. By joining our team, you’ll contribute to the development, manufacturing, and delivery of innovative medicines that help people live longer, fuller, and healthier lives.

Our award-winning culture thrives on collaboration, innovation, and scientific excellence. If you’re energized by challenges and the opportunities they bring, Amgen is the place for you. Join us to transform patients’ lives while advancing your career.


Senior Manager - Regulatory Data and Analytics

Your Role
As part of the Global Submission and Information Management (GSIM) team, you’ll bring strategic expertise to enhance operational excellence and compliance in Amgen's regulatory submission and information management. Your role will focus on shaping Amgen’s regulatory data and analytics strategy, building a high-performing team, and driving data standards, insights, and process improvements.


Key Responsibilities

  • Build and lead a team delivering global regulatory data and analytics services across systems and processes.
  • Ensure compliance with international data standards and health authority regulations for submission and registration.
  • Collaborate with Global Regulatory Affairs and Strategy (GRAAS) to identify regulatory data and analytics needs.
  • Develop and implement strategies for regulatory data standards, analytics, and reporting.
  • Partner with Digital Technology and Innovation (DTI) to develop a multi-year roadmap for regulatory data standards and insights.
  • Enhance data visibility and accessibility to enable leadership to make informed decisions efficiently.
  • Establish scalable standards for maintaining and updating (meta)data.
  • Leverage global regulations to simplify, automate, and innovate systems and processes.
  • Present data through intuitive, interactive, and graphical summaries to improve performance insights and decision-making.

What You Bring

Basic Qualifications

  • Doctorate degree with 2+ years of regulatory systems experience OR

  • Master’s degree with 8-10 years of regulatory systems experience OR

  • Bachelor’s degree with 10-14 years of regulatory systems experience OR

  • Associate’s degree with 14-18 years of regulatory systems experience.

  • Advanced knowledge of Veeva Vault.

  • Leadership experience in regulatory data analytics and reporting.

  • Expertise in data-centric processes and systems.

  • Strong skills in managing structured and unstructured data.

  • Proven excellence in change management and stakeholder engagement.

Preferred Qualifications

  • 5+ years’ experience in Regulatory Affairs.
  • Demonstrated success in delivering enterprise-wide data strategies.
  • Ability to create business cases with accurate cost and effort estimates.
  • Deep understanding of IDMP and Regulatory Affairs complexities.
  • Proficiency in data visualization tools (e.g., Tableau, Spotfire).
  • Proven experience building and leading high-performing teams.
  • Strong analytical thinking and learning agility.
  • Advanced collaboration skills with global stakeholders.

Why Join Amgen?

We’re committed to supporting your professional growth and personal well-being. From competitive benefits to a collaborative work environment, we provide the resources you need to thrive.

Amgen offers a competitive salary along with a comprehensive Total Rewards package aligned with industry standards.


Apply Today
Take the first step toward a career that defies imagination. Visit careers.amgen.com to apply.


Amgen is an Equal Opportunity Employer
We welcome all qualified applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected category.

If you require accommodation to participate in the application or interview process, perform essential job functions, or access other employment benefits, please contact us.