Internal Medicine, FDA - Physician - Clinical Reviewer - Internist Job at AE Strategies, Silver Spring, MD

N0FPTDN0c1llTndyT3lLdUZrbVRsSWFoUlE9PQ==
  • AE Strategies
  • Silver Spring, MD

Job Description

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.

Job Tags

Permanent employment, Full time, Weekend work, 1 day per week,

Similar Jobs

Liberty Personnel Services, Inc.

Mobile IOS/Android UI/UX Designer Job at Liberty Personnel Services, Inc.

 ...Job Details: Mobile IOS/Android UI/UX Designer My client is seeking a candidate with 5-7 years experience in UI/UX design for web and mobile applications. The ideal candidate will have a strong handle on front-development technologies coupled with responsive design... 

TMC - CDL-A Recent Graduate

CDL-A Truck Driver - Home Weekends - Earn Up to + Benefits Job at TMC - CDL-A Recent Graduate

 ...TMC is now hiring CDL-A Recent Graduates - No Experience? No Problem Why Choose TMC? Home every weekend - our drivers typically run within a 1,200-mile radius of their home Drivers earn up to $100,000 per year Earn $1,350 - $1,600 per week ~... 

EFC International

Dynamics CRM Developer - Remote or Hybrid Work Schedule Job at EFC International

 ...requirements. We solve problems. If you thrive in a collaborative environment, we want to hear from you! Position Overview: As a Remote Dynamics CRM Developer, you will play a key role in designing, developing, and customizing Microsoft Dynamics CRM solutions to meet the... 

Vestas

Technician II Job at Vestas

 ...technical wind industry experience, OR six (6) months technical wind industry experience and a certificate of completion from a Wind Technician program, OR in absence of technical wind industry experience, minimum three (3) years' experience working with hydraulic,... 

Cardinal Health

Pharmacy Services - Delivery Driver Job at Cardinal Health

 ...What Pharmacy Services & Delivery contributes to Cardinal Health Responsible for the prompt and accurate delivery and distribution of radiopharmaceuticals or oncology pharmaceuticals to medical care providers in accordance with customer demand and requirements of the...