Physician Reviewer
4 days ago
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.
-
Physician Reviewer
6 days ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Title: FDA - Physician - Trial Reviewer - PsychiatryAbout the Role:We are seeking a highly skilled Physician to join our team as a Trial Reviewer in the Psychiatry department at the FDA. As a key member of our team, you will play a critical role in ensuring the safety and efficacy of new drugs.Responsibilities:Review new drug applications to ensure they...
-
Physician Clinical Reviewer
3 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Summary:The Clinical Trial Reviewer is a full-time physician position with AE Strategies, a leading healthcare consulting firm. This hybrid role requires candidates to live within commutable distance of our headquarters and be willing to report to the office at least one day per week. Our team follows traditional working hours with no overtime or weekend...
-
Physician Reviewer
3 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Summary:The Clinical Trials Reviewer is a key position at AE Strategies, requiring a physician with expertise in regulatory affairs and clinical trials. This role involves reviewing new drugs to ensure their safety and efficacy, working closely with the team to make evidence-based decisions, and staying up-to-date on scientific...
-
Physician Reviewer
2 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeJob SummaryWe are seeking a highly skilled Physician 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 reviewing Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for prescription...
-
FDA Physician
3 days ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Title: FDA Physician - Urologist Clinical Trial ReviewerAE Strategies is proud to partner with the FDA to recruit a skilled Clinical Trial Reviewer for their team. As a full-time physician position, this role requires a strong understanding of clinical and scientific knowledge to review new drugs and ensure their safety and effectiveness.About the...
-
FDA Physician Clinical Reviewer Cardiologist
6 days ago
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleThe Clinical Trial Reviewer is a full-time physician position with the FDA, requiring a strong foundation in cardiology. As a hybrid role, candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and be willing to report to the office at least one day per week.A Day in the LifeAs a cardiology expert for the...
-
FDA Physician Clinical Reviewer Cardiologist
2 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleThe Clinical Trial Reviewer is a full-time physician position with the FDA, requiring a strong foundation in cardiology. As a hybrid role, candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and be willing to report to the office at least one day per week.A Day in the LifeAs a cardiology expert for the...
-
Physician Reviewer
6 days ago
Silver Spring, Maryland, United States AE Strategies Full timeJob Title: Clinical Trial ReviewerThe Clinical Trial Reviewer is a full-time position with the FDA, requiring a physician to live within commutable distance of the FDA Headquarters in Silver Spring, MD, and report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.About the Role:As an expert...
-
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleThe Clinical Trial Reviewer is a full-time physician position with the FDA, requiring a strong foundation in clinical and scientific knowledge. As a hybrid role, candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and be willing to report to the office at least one day per week.A Day in the LifeAs an...
-
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleThe Clinical Trial Reviewer is a full-time physician position with the FDA, requiring a strong foundation in pulmonology and critical care medicine. This hybrid role demands a balance between remote work and in-office presence, with a minimum of one day per week spent at the FDA Headquarters in Silver Spring, MD.The team operates within...
-
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleThe Clinical Trial Reviewer is a full-time physician position with the FDA, requiring a strong foundation in pulmonology and critical care medicine. This hybrid role demands a balance between working from home and reporting to the office at least one day a week, necessitating a commutable distance from the FDA Headquarters in Silver Spring,...
-
Clinical Review Physician at FDA
1 month ago
Silver Spring, Maryland, United States AE Strategies Full timeResponsibilities of Medical Officers at AE Strategies include:Verifying that all pharmaceuticals produced for interstate commerce are both safe and effective, accompanied by accurate and informative labeling.Ensuring the safety, efficacy, and quality of vaccines, blood products, certain diagnostic tools, and other biological and biotechnology-derived human...
-
Clinical Review Physician at FDA
1 month ago
Silver Spring, Maryland, United States AE Strategies Full timeRole Overview:The position of Medical Officer at the FDA encompasses a range of critical responsibilities aimed at safeguarding public health.Drug Safety Assurance: Guaranteeing that all human pharmaceuticals produced for interstate commerce are both safe and effective, accompanied by accurate and informative labeling.Biological Product Oversight: Monitoring...
-
Clinical Review Physician at FDA
1 month ago
Silver Spring, Maryland, United States AE Strategies Full timeOverview of Responsibilities:Medical officers at the FDA are tasked with ensuring that all pharmaceuticals produced for interstate commerce are both safe and effective, accompanied by accurate and informative labeling.They are responsible for safeguarding the safety, potency, purity, and efficacy of vaccines, blood products, certain diagnostic tools, and...
-
FDA Physician
2 days ago
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleAs a Clinical Trial Reviewer with the FDA, you will play a critical role in ensuring the safety and efficacy of new drugs. This is a unique opportunity to apply your clinical and scientific knowledge to complex medical problems and make a meaningful impact on public health.ResponsibilitiesReview new drugs to ensure they meet safety and efficacy...
-
Clinical Trial Reviewer
2 weeks ago
Silver Spring, Maryland, United States AE Strategies Full timeAbout the RoleWe are seeking a highly skilled Clinical Trial Reviewer to join our team at the FDA. As a key member of our team, you will play a critical role in ensuring the safety and efficacy of new drugs.ResponsibilitiesReview new drugs to ensure they meet regulatory requirementsEvaluate clinical trial results and labeling accuracyWork with your team to...
-
Medical Officer
6 days ago
Silver Spring, Maryland, United States AE Strategies Full timeMeaningful Contributions to Public HealthAs a Medical Officer at the FDA, you will have the opportunity to make a significant impact on public health by ensuring the safety and effectiveness of medical products. This role is ideal for physicians who want to expand their reach and contribute to the global public good.Key Responsibilities:Ensure the safety and...
-
Primary Care Physician
2 days ago
Silver Spring, Maryland, United States MFA Co Full timeJoin Our Team as a Primary Care PhysicianThe George Washington University Medical Faculty Associates, an independent non-profit academic clinical practice group affiliated with The George Washington University, is seeking a Board certified/board eligible internal medicine or family medicine physician for a full-time position on our GW Primary Care staff in a...
-
Clinical Reviewer
1 month ago
Silver Spring, Maryland, United States AE Strategies Full timeRole Overview:As a physician within the FDA, you will play a crucial role in safeguarding public health and enhancing community well-being on a national scale.Key Responsibilities:As a medical officer, your responsibilities will include:1. **Evaluating Human Drugs:** Ensuring that all human pharmaceuticals produced for interstate commerce are safe,...
-
Clinical Reviewer
1 month ago
Silver Spring, Maryland, United States AE Strategies Full timeOverview:Physicians play a crucial role in enhancing the health and welfare of their communities. While this contribution is highly esteemed, a position with the Food and Drug Administration (FDA) allows medical professionals to impact public health on a much larger scale.Key Responsibilities:As a medical officer at the FDA, your responsibilities will...