Biomedical consulting firm is currently seeking a Medical Writer to join our Bethesda, MD team. This position involves preparing scientific and regulatory documents on behalf of government 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 and editing manuscripts, meeting reports and proceedings, and safety documents; and data analysis.
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. A background in oncology and/or immunology is highly desirable. Requires excellent oral, written, data interpretation, and computer skills (experience with PC-based systems and MS Office required) and high attention to detail; familiarity with database design, FDA regulations, and/or clinical research highly desirable. For Senior Medical Writer, 3+ years of experience in the medical/regulatory writing field in the pharmaceutical/biotech industry or CRO environment strongly preferred.
PSI International, Inc. is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.