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Job #03509

About our client Our client is a privately held Contract Research Organization that is Headquartered in Maryland. They provide Biotech/pharma company CRO services for clinical trials (Phase I-IV) in a variety of therapeutic areas including CNS, Infectious diseases, Pain, Dermatology, etc. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of it's employees. Position Location Medical Director Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Evaluates and prepares periodic safety reports for marketed and investigational drugs for FDA submission. 2) Reviews, evaluates and edits expedited safety reports for marketed and investigational drugs for FDA submission. 3) Prepares clinical and non-clinical data section of the Annual Report for marketed drug products for submission. 4) Investigates and provides reports of adverse drug experiences for marketed and investigational drug products. 5) Provides medical monitoring for clinical trials. 6) Assists in the development of risk evaluation and mitigation strategies. 7) Conducts medical review of case reports. 8) Works with IT staff to develop ad hoc reports for signal detection and trend analysis. 9) Provides oversight, training and coaching for the members of the Medical Affairs department. 10) Reviews and evaluates drug safety data from safety database or clinical study reports in response to client or FDA Request. 11) Codes adverse drug experiences and drug for clinical trial and post marketing drug safety surveillance. 12) Develops Standard Operating Procedures (SOPs) for drug safety surveillance, adverse event and drug coding and other activities of the Medical Affairs department. 13) Updates package inserts and poison control monographs of marketed drug products. 14) Provides consultation to Research Operations and IT staff, clinical study site personnel and communicates regularly with clients. Requirements 1) Medical degree required. 2) 7-10 years of medical or clinical experience including research and drug safety monitoring with post marketing experience. 3) 3-5 years of supervisory experience. 4) Demonstrated knowledge of FDA regulations and guidelines, including International Conference Harmonization (ICH) and Good Clinical Practices (GCP). 5) Excellent spoken and written communication skills. 6) Excellent organizational and time management skills. 7) Computer literacy.