Physician Reviewer

4 days ago


Silver Spring, Maryland, United States AE Strategies Full time
Job Title: Clinical Trial Reviewer - Anesthesiology and Pain Management

We are seeking a highly skilled Clinical Trial Reviewer to join our team at the FDA. As a key member of our Division of Anesthesiology, Addiction Medicine, and Pain Medicine, you will play a critical role in ensuring the safety and efficacy of new drugs and biologics.

About the Role:

As a Clinical Trial Reviewer, you will be responsible for reviewing Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for prescription drugs and biologics intended for the prevention, treatment, or diagnosis of conditions including:

  • Acute Pain, e.g.:
    • Surgical and procedural pain
    • Pain due to trauma/injury
    • Pain due to acute inflammatory processes
  • Chronic pain, e.g.:
    • Cancer pain
    • Neuropathic pain
    • Fibromyalgia
    • Osteoarthritis Pain
    • Low back pain
  • Addiction, e.g.:
    • Nicotine
    • Alcohol
    • Stimulants
    • Opioids

You will work closely with your team to make evidence-based decisions, analyzing summaries from other experts and recommending approving, requesting more data, or rejecting applications. You will also consult with other specialists to address complex issues and stay up to date on scientific advancements.

Requirements:

To be successful in this role, you will need:

  • A US or Canadian Medical Degree (MD, DO, or equivalent) from an accredited school
  • A current, active, full, and unrestricted medical license in the US or its territories
  • Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management
  • Enjoys solving unique problems and addressing challenges in drug/biologic regulatory review
  • Desire to stay current on the latest clinical information in your assigned therapeutic area
  • Capable of strong written and verbal communication

We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for regulatory review, we encourage you to apply for this exciting opportunity.


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