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Sr. Medical Scientist - UPLIZNA

Amgen
over 2022 years ago
Remote friendly (United States)
United States
Medical Affairs

Role Summary

Senior Medical Scientist, Uplizna — in this vital role you will serve as a key medical reviewer and scientific expert, ensuring the accuracy, balance, and compliance of US medical and promotional materials while contributing to broader US Medical strategy and execution.

Responsibilities

  • Serve as the primary US Medical reviewer for promotional, non-promotional, and disease state materials
  • Ensure all materials are scientifically accurate, balanced, and aligned with the US Prescribing Information, regulatory guidance, and internal policies
  • Provide clear, evidence based medical rationale and risk assessment during review discussions
  • Review and approve field medical materials, including reactive content, slide decks, scientific response documents, and training materials
  • Contribute to the development and execution of the US Medical Plan for UPLIZNA
  • Translate clinical and scientific data into actionable medical insights that inform US strategy
  • Provide scientific input into brand planning and lifecycle management activities
  • Support the development of value messaging, payer materials, and HEOR related initiatives in collaboration with cross functional partners
  • Provide medical input into advisory boards, congress planning, and medical symposia as appropriate
  • Ensure high quality dissemination of clinical and scientific data through compliant medical communications

Qualifications

  • Required: Doctorate degree and 2 years of Medical Affairs experience
  • Required: Master’s degree and 4 years of Medical Affairs experience
  • Required: Bachelor’s degree and 6 years of Medical Affairs experience
  • Required: Associate’s degree and 10 years of Medical Affairs experience
  • Required: High school diploma / GED and 12 years of Medical Affairs experience
  • Preferred: PharmD, PhD, MD, or DO
  • Preferred: Experience serving as a medical reviewer within a Promotional Review Committee or similar governance process
  • Preferred: Strong understanding of medical legal regulatory review processes
  • Preferred: Experience in rare disease a plus
  • Preferred: Demonstrated ability to interpret and apply clinical data in a compliant, strategic manner
  • Preferred: Strong scientific communication skills with the ability to clearly articulate medical rationale in cross functional settings
  • Preferred: Ability to manage multiple competing priorities in a fast-paced environment