Medical Director

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Position : Medical Director

Salary : 20-25 Million Yen

JobRef : 100

Date : 21 January 2012

Location : Tokyo

 

Function

  • Provide medical monitoring for assigned projects
  • Review all documents assigned for scientifically/medically relevant issues including drug safety
  • Function as medical representative/technical lead/senior technical lead on the projects, in Proposal Development Team and/or client meetings
  • Provide advice and support for feasibility studies

Key Accountabilities

  • Medical monitoring – answering day to day medical and scientific questions, provide daily medical support to staff or site (investigator/study coordinator)
  • Review and sign off adverse events reports for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide reports to European Regulatory Authorities, FDA or other regulatory agencies; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities
  • Provide medical input into Pharmacovigilance workflows and projects as required.
  • Review and sign off Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities
  • Review and sign off technical documents with respect to medically relevant matters with particular attention to those relating to drug safety
  • 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 in conjunction with clients/sponsors or in conjunction with other departments
  • Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings)
  • Maintain up-to-date knowledge of therapeutic area expertise by attending Professional Society Meetings
  • Provide support for marketing activities as requested
  • Provide medical expertise to client as contracted
  • Provide medical expertise and training to other personnel, as required
  • Maintain a current medical license.

Skills

  • Experience in clinical medicine (general or specialist qualifications) with a specialty in a “therapeutic area” which is expected to be kept up-to-date
  • Excellent knowledge of drug safety and the drug development process
  • Excellent presentation skills
  • Excellent interpersonal skills
  • Excellent verbal / written communication skills
  • Excellent time management skills
  • Client focused approach to work

Education

  • Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills

  • Fluent English

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