Job Opportunities

FDA's Office of New Drugs Silver Spring, MD Clinical Analyst Other
Job ID JL1272 posted on 02/10/20

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. 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. The Division of Hepatology and Nutrition (DHN) within the Office of Immunology and Inflammation (OII) is seeking highly qualified nutritionists/dieticians to serve as clinical analysts.

The clinical analyst is responsible for reviewing and evaluating INDs, NDAs, and associated submissions, such as clinical study protocols and their amendments, safety reports, and labeling supplements; providing regular updates and recommendations to clinical reviewers and clinical reviewer team leaders on assigned portfolio of regulatory submissions; analyzing and summarizing clinical trial data submitted by industry or individual investigators during review of regulatory submissions; conducting literature search and compiling data to prepare reports related to the work of the Division and develop background data pertinent for FDA programs, as assigned; assisting in the development and conducting training programs and other educational activities, such as workshops and conferences; and representing the Division at meetings on matters concerning regulated products. As a clinical analyst, 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.

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).

Minimum Qualifications

Applicants must have a graduate/higher level degree with a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. 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 apply for staff fellowship appointments. Excellent oral and written communication skills and an ability to work effectively on a team are necessary to be successful in this role.

Desired Qualifications

A competitive candidate will have experience working with clinical data with enough knowledge and understanding of clinical trial design to evaluate extensive, long-range scientific programs, and their implications on the drug development process. Prior human subject research experience is desired, but not required.

Contact

OND External Recruitment Team
301-796-0800
ond-employment@fda.hhs.gov


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