SilverSpringRecruiter Since 2001
the smart solution for Silver Spring jobs

Non Clinical Reviewer

Company: Food and Drug Administration
Location: Silver Spring
Posted on: December 4, 2019

Job Description:

Education - Doctoral Degree Skills - Teaching Experience - Ophthalmology Experience - Clinical Trials Benefits - Loan Repayment Program - Life Insurance - Health Insurance Position Description: Are you making a difference contributing to the public health and well-being of millions of Americans? Would you like to? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are always looking for committed individuals to help us achieve our mission. CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER's drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law. OND's public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufactures in support of New Drug and Investigational New Drug applications (NDA/IND), and to determine if candidate drugs are safe and effective. OND is seeking scientists to serve as nonclinical reviewer's in various drug review divisions. Salary & Benefits: Civil service salary starting at the GS-13 level; Excellent federal government benefits package (health insurance, life insurance, retirement, etc.); Relocation expenses and student loan repayment may be paid to eligible candidates; Flexible and/or partial telework schedules available (after completion of initial training period). Responsibilities: The nonclinical reviewer is responsible for reviewing and evaluating the results of nonclinical pharmacologic, toxicologic, and pharmacokinetic studies submitted in support of INDs, NDAs, and BLAs; these studies assess drug safety based on studies conducted by the drug developer. Review of the nonclinical pharmacologic and toxicologic data includes evaluation of the quality and adequacy of the various assessments and studies. These reviews serve as the basis for calculating initial safe starting doses in clinical trials, doses for longer duration clinical trials, and for product labeling (the package insert). Nonclinical reviewers prepare a comprehensive review of the data and submit recommendations and conclusions for consideration of the review team. As a nonclinical reviewer, you will have the opportunity to: Advance the public health through new drug development; Experience teaching and training opportunities; Interact with pharmaceutical companies; and Work with a wide range of scientific disciplines in a team-oriented atmosphere. Qualifications: Applicants must have a doctorate degree in pharmacology, toxicology, or a related field from an accredited university. Any applicants with ocular and/or ophthalmology-related experience should state it in their cover letter when submitting their application. Foreign graduates must have their transcripts and degrees evaluated by a credential evaluation service that is recognized by the National Association of Credential Evaluation Services (NACES) or the Association of International Credentials Evaluators (AICE). Candidates must be U.S. citizens. Permanent U.S. residents may for staff fellowship appointments. To: Please send a current CV/resume and cover letter to ************************** for consideration. Please reference source code: #20-000EG in the subject line of the email. FDA is an equal opportunity employer with a smoke free environment.

Keywords: Food and Drug Administration, Silver Spring , Non Clinical Reviewer, Healthcare , Silver Spring, Maryland

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Physician - Dermatologist (111104)
Description: JOB CODE: 111104 Physician - Dermatologist LOCATION: Berks County PA Join a thriving and growing regional integrated hospital system in Southeastern Pennsylvania with a rich history of providing high-quality, (more...)
Company: Veritas Global Consulting Group, LLC
Location: Lancaster
Posted on: 12/12/2019

Travel Nurse RN - Labor and Delivery - $1,783 per week
Description: NurseFly Travel Nursing with Stability Healthcare is seeking a labor and delivery travel nurse for a travel nursing job in Leesburg, Virginia: br br br ul br li Specialty: Labor and Delivery (more...)
Company: NurseFly Travel Nursing
Location: Leesburg
Posted on: 12/12/2019

Lancaster - Licensed Practical Nurse (LPN)
Description: Who We Are: connectRN is a technology platform built by nurses, for nurses. Through the connectRN app, facilities post their open shifts that clinicians can view and apply for. Whether it's full time (more...)
Company: ConnectRN
Location: Lancaster
Posted on: 12/12/2019


Charge Nurse (RN/LPN) - Skilled Care
Description: : Our faith-based mission is to enrich the lives of residents, staff and the community. Must have a passion for helping older adults, positive outlook and be a team player. We offer a pleasant, upbeat, (more...)
Company: Mennonite Home Communities
Location: Lancaster
Posted on: 12/12/2019

Travel Nurse RN - Cardiac Cath Lab - $2,213 per week
Description: NurseFly Travel Nursing with LRS Healthcare is seeking a cardiac cath lab travel nurse for a travel nursing job in Leesburg, Virginia: br br br ul br li Specialty: Cardiac Cath Lab br li (more...)
Company: NurseFly
Location: Leesburg
Posted on: 12/12/2019

Registered Nurse (RN) - Pediatrics
Description: SunIRef:Nurse:title Registered Nurse RN - Pediatrics BAYADA Home Health Care 2,306 reviews - Lancaster, PA Part-time BAYADA Home Health Care 2,306 reviews Read what people are saying about working here. (more...)
Company: BAYADA Home Health Care
Location: Lancaster
Posted on: 12/12/2019

Registered Nurse - Home Health Visits
Description: SunIRef:Nurse:title Registered Nurse - Home Health Visits BAYADA Home Health Care 2,329 reviews - Lancaster, PA 17111 Part-time BAYADA Home Health Care 2,329 reviews Read what people are saying about (more...)
Company: BAYADA Home Health Care
Location: Lancaster
Posted on: 12/12/2019

Travel Surgical Tech - $1,247 per week
Description: NurseFly Travel Nursing with Advanced Travel Nursing is seeking a travel surgical tech for a travel job in Leesburg, Virginia: br - Specialty: Surgical Tech br - Discipline: Allied Health Professional (more...)
Company: NurseFly Travel Nursing
Location: Leesburg
Posted on: 12/12/2019

Travel Nurse RN - Med Surg - $1,515 per week
Description: NurseFly Travel Nursing with LRS Healthcare is seeking a med surg travel nurse for a travel nursing job in Leesburg, Virginia: br br br ul br li Specialty: Med Surg br li Discipline: RN (more...)
Company: NurseFly
Location: Leesburg
Posted on: 12/12/2019

Travel Physical Therapist - $1,713 per week
Description: NurseFly Travel Nursing with Advanced Travel Therapy is seeking a travel physical therapist for a travel job in Lancaster, Pennsylvania: br br br ul br li Specialty: Physical Therapist br (more...)
Company: NurseFly
Location: Lancaster
Posted on: 12/12/2019

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Silver Spring RSS job feeds