FDA - Physician - Clinical Reviewer - Gastroenterologist

4 weeks ago

Silver Spring MD, United States AE Strategies Full time

The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.

A Day in the Life:

As an infectious disease expert for the FDA, you will review new drugs to ensure that theyre safe and effective.

  • Before testing on humans: You will check if the drugs design is sound and backed by strong animal testing.
  • For approval: You will evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.
  • For existing drugs: You will review updates, safety reports, and potential new uses or label changes.

You will work with your team to make evidence-based decisions.

  • You will analyze summaries from other experts and recommend approving, requesting more data, or rejecting applications.
  • You will consult with other specialists to address complex issues and stay up to date on scientific advancements.
  • You will share your expertise through conferences and publications.

Position Requirements:

Education:

  • US or Canadian Medical Degree: MD, DO, or equivalent from an accredited school.
  • Foreign Medical Degree: MD or equivalency, such as a ECFMG certification or USMLE completion.

Licensure:

  • Current, active, full, and unrestricted medical license in the US or its territories.

Needed Experience:

  • 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.

  • FDA - Physician - Clinical Trial Reviewer - Hematologist

    4 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As a...

  • FDA Physician

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Clinical Trial Reviewer - Hematologist

    7 days ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As a...

  • FDA - Physician - Clinical Trial Reviewer - Hematologist

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As a...

  • FDA Physician

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Clinical Trial Reviewer - Cardiologist

    1 week ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Campus in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As a...

  • FDA - Physician - Trial Reviewer - Urology

    4 weeks ago

    Silver Spring, MD, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours. A Day in the Life: As...

  • FDA Physician Clinical Reviewer

    2 months ago

    Silver Spring, MD, United States AE Strategies Full time

    Medical officers at FDA perform duties that: Ensuring all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labeling Ensuring the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human products Ensuring...

  • FDA - Clinical Reviewer - Pharmacologist/Toxicologist/Biologist

    4 weeks ago

    Silver Spring, MD, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours. A Day in the Life: As...

  • FDA- Physician Clinical Reviewer- Thoracic Oncology

    2 months ago

    Silver Spring, MD, United States AE Strategies Full time

    Meaningful & Mission-Driven Physicians generally contribute to the overall health and wellbeing of their communities in very meaningful ways. This is of course valued and respected but working with the Food and Drug Administration (FDA) offers physicians a way to contribute to the overall public good on a far greater scale. If you are interested in...

  • FDA- Physician Clinical Reviewer- Thoracic Oncology

    2 months ago

    Silver Spring, MD, United States AE Strategies Full time

    Meaningful & Mission-Driven Physicians generally contribute to the overall health and wellbeing of their communities in very meaningful ways. This is of course valued and respected but working with the Food and Drug Administration (FDA) offers physicians a way to contribute to the overall public good on a far greater scale. If you are interested in...

  • FDA - Physician - Clinical Reviewer - Nuclear Medicine

    2 months ago

    Silver Spring, MD, United States AE Strategies Full time

    Physicians generally contribute to the overall health and wellbeing of their communities in very meaningful ways. This is of course valued and respected but working with the Food and Drug Administration (FDA) offers physicians a way to contribute to the overall public good on a far greater scale. If you are interested in expanding your reach to include a...

  • FDA - Physician - Clinical Reviewer - Pulmonologist/Critical Care Physician

    4 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Clinical Reviewer - Endocrinology

    2 months ago

    Silver Spring, United States AE Strategies Full time

    Meaningful & Mission-DrivenPhysicians generally contribute to the overall health and wellbeing of their communities in very meaningful ways. This is of course valued and respected but working with the Food and Drug Administration (FDA) offers physicians a way to contribute to the overall public good on a far greater scale. If you are interested in...

  • FDA - Physician - Clinical Reviewer - Infectious Disease

    2 months ago

    Silver Spring, MD, United States AE Strategies Full time

    Meaningful & Mission-Driven Physicians generally contribute to the overall health and wellbeing of their communities in very meaningful ways. This is of course valued and respected but working with the Food and Drug Administration (FDA) offers physicians a way to contribute to the overall public good on a far greater scale. If you are interested in...

  • FDA - Physician - Trial Reviewer - Psychiatry

    4 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD, and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • Physician (Office of Therapeutic Products)

    3 weeks ago

    Silver Spring, United States FDA Full time

    _**Title 21 Vacancy Announcement**_ - **Department of Health and Human Services (HHS)**_ - **Food and Drug Administration (FDA)**_ - **Center for Biologics Evaluation and Research (CBER)**_ - **Office of Therapeutic Products (OTP)**_ **Area of Consideration**: The Public United States Citizenship is required. You must be a U.S. Citizen or U.S. National....

  • FDA Physician Clinical Reviewer

    2 months ago

    Silver Spring, United States AE Strategies Full time

    Medical officers at FDA perform duties that:Ensuring all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labelingEnsuring the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human productsEnsuring the...

  • FDA Physician Clinical Reviewer

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    Medical officers at FDA perform duties that:Ensuring all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labelingEnsuring the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human productsEnsuring the...

  • FDA - Clinical Reviewer - Pharmacologist/Toxicologist/Biologist

    4 weeks ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...