Regulatory Affairs Specialist
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POST DATE 8/17/2016
END DATE 10/28/2016
JOB DESCRIPTIONWe are seeking a Regulatory Affairs Specialist for USAMMDA in Frederick, MD!
ClinicalRM is a full service Contract Research Organization (CRO) specializing in preclinical through Phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe, and respond rapidly to global health crises.
* Assist Regulatory Scientist Staff with regulatory tasks as needed (i.e. Regulatory submission coordination/review, annual report tracking and preparation etc.).
* Provide support for entering clinical trials protocol information and study results into the NIH Clintrials.gov database ensuring that the database is kept current and accurate.
* Assist Regulatory Scientist Staff with ensuring essential regulatory documents are maintained in the sponsor's electronic regulatory files as needed.
* Possess a minimum of a bachelor's degree in related field or equivalent experience.
* Demonstrated experience supporting U.S.FDA regulated product development efforts.
* Good working knowledge of various FDA submission types and forms for drugs/biologics.
* Good working knowledge of clinical protocols and familiarity with clinical study design.
* Attention to detail, strong written and verbal communication skills and ability to work independently are essential.
* Position will require a Secret security clearance.
* Prior experience with entering clinical trial information with ClinTrials.gov database is preferred including experience interpreting/retrieving clinical study results from final study reports for entry into the database.
* Prior experience with eCTD compliant regulatory submissions
ClinicalRM is an Affirmative Action-Equal Opportunity Employer