This position involves preparing scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator's Brochures), performing literature searches, preparing meeting reports and proceedings, safety documents and/or data analysis.
Desired Skills and Experience
Requirements include an M.S. degree or equivalent with 3 or more years of relevant work experience or a Ph.D. in pharmacology, biochemistry, molecular biology, immunology, or a related field. Requires excellent oral, written and computer skills and attention to detail; familiarity with database design, FDA regulations, and/or clinical research highly desirable.
About this company: http://www.tech-res.com/
Founded in 1979, Technical Resources International, Incorporated (TRI) is a certified Hispanic woman-owned full service contract research organization plus (CRO+). We provide product development support services to the global drug, biologic, vaccine, medical device, and health sector communities through the effective combination of scientific, clinical, information technology, and communication services.
For more than three decades, TRI has provided high quality services to clinical trial sponsors in the public and private sector. TRI's success is based on the competence of our staff denoted by their qualifications and experience; and on the high level of client satisfaction as evidenced by the number of repeat business.
We possess the customer focus of a mid-sized company, the adaptability of a seasoned contractor, and the global footprint of a large CRO. Headquartered in Bethesda, MD, TRI has been ranked among the fastest growing privately-owned companies in the U.S. under the Inc.500 | 5000 and in the top 500 Diversity-owned companies in the U.S. by Diversity Business.