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