Parexel's Medical Sciences team is growing, and we currently have a fantastic opportunity for a Pulmonologist to join Parexel's highly recognized Global Medical Sciences Team! As a M edical Director you will work closely with some of the best and brightest Leaders in the Industry and assist our clients in their journeys of getting new and innovative drug treatments into the hands of those who need them most.
Overall responsibilities of the Medical Director are to :
and assume the role of Senior Technical Lead in selected circumstances.
Specific responsibilities include : Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness.
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor, depending on the contract.
Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, sponsor, investigator, and FDA.
Review documents written by various Parexel divisions for safety issues. Review coding of adverse events and concomitant medications for accuracy and consistency.
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients / sponsors or in conjunction with clients / sponsors and in conjunction with other Parexel divisions.
Attend and present material, as requested, at meetings within Parexel as well as extra-company meetings (such as investigator meetings).
Maintain up-to-date knowledge of projects by attending Professional Society Meetings. Provide support for Marketing activities as requested.
Assume the role of Senior Technical Lead in selected circumstances. Provide medical consultation as required or requested to client / sponsor or to other Parexel divisions QualificationsBoard certificated / board eligible or regional equivalency in Pulmonary and Critical Care with clinical experience is preferred with past related experience as a physician in Industry or as a clinical trial investigator a plus.
However, experienced Medical Monitors with strong General Medicine experience coupled with a strong interest in Respiratory Medicine will also be considered.
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