We are currently seeking Board Certified Oncologists and Hematologists to join PAREXEL as Medical Directors.
As a Medical Director at PAREXEL, you will provide medical monitoring for assigned projects; function as medical representative on the project team; provide medical consultation as required or requested to client/sponsor or to other PAREXEL service groups; and assume the role of Senior Technical Lead in selected circumstances.
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.
Qualifications
Successful applicants will be Board certified in Hematology and/or Oncology with extensive clinical experience. Experience as a Physician in Industry or as a clinical trial investigator is a plus. Fluency in Mandarin is also a plus!
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