Gastroenterologist
Company: FDA Office of New Drugs
Location: Silver Spring
Posted on: February 14, 2021
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Job 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, Center for Drug Evaluation and
Research, Office of New Drugs 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. ONDs 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, and to
determine if candidate drugs are safe and effective. The Division
of Gastroenterology within the Office of Immunology and
Inflammation is seeking highly qualified gastroenterologists to
serve as clinical reviewers. We are seeking individuals who are
board certified or board eligible in gastroenterology and/or
hepatology (adult or pediatric).-- We are seeking individuals who
are board certified or board eligible in gastroenterology.-- We are
particularly interested in individuals with expertise and/or
interest in functional GI, motility, or pancreatic disorders;
however, others are also encouraged to apply. Graduating fellows
and junior faculty are encouraged to apply.-- Primary
responsibilities of the clinical reviewer include the following:
Determines whether clinical trials of new drugs and therapeutic
biologics in humans are soundly conceived and supported to justify
human testing Reviews clinical protocols and provides input
regarding study design Together with other team members, interacts
with investigators and industry sponsors to guide development of
drugs and therapeutic biologics Determines whether marketing
applications should be approved based on an evaluation of the
evidence of safety and effectiveness Consults, when needed and
where appropriate, with other medical specialists and scientists
within and outside FDA Assists in the development and conduct of
training programs and other educational activities, such as
workshops and conferences Keeps abreast of the progress in medical
and related sciences by reviewing the scientific literature and
participating in staff seminars where cases and special topics are
discussed As a clinical 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. This is primarily a non-clinical
position; there is an option to provide one half-day per week of
clinical care, if interested. SALARY & BENEFITS Salary is
commensurate with experience and expertise 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). QUALIFICATIONS Applicants must have a Doctor of Medicine
or Doctor of Osteopathy degree from an accredited medical school.
Graduates of foreign medical schools must be certified by the
Education Commission for Foreign Medical Graduates (ECFMG).
Candidates must be U.S. citizens. Permanent U.S. residents may
apply for staff fellowship appointments. The candidate will
interact extensively with others within FDA, academia and industry
and should have excellent written and oral communication skills.--
Prior research experience is desired, but not required. FDA
provides extensive educational programing for new Medical Officers.
This includes formal training in clinical trial design and conduct,
biostatistics, clinical pharmacology, toxicology, regulatory
science, technical writing, and other topics of interest.
Certification by or eligibility for the American Board of Internal
Medicine (ABIM) in gastroenterology, or American Board of
Pediatrics (ABP) in pediatric gastroenterology, is required. FDA IS
AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT Are you
making a difference contributing to the public health and
well-being of millions of Americans? Would you like to? The
physicians, scient
Keywords: FDA Office of New Drugs, Silver Spring , Gastroenterologist, Healthcare , Silver Spring, Maryland
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