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Job Details

Medical Director (Multiple European Locations Considered)

Company: PAREXEL
Location: Uxbridge, England,United Kingdom
Reference: 42326BR
Closing Date: 25 Mar 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

Job PurposeThis individual will provide medical monitoring for assigned projects. He/She will be responsible for reviewing all documents assigned for scientifically.medically relevant issues, including drug safety. They will function as a medical representative on projects, in the proposal development team and/or in client meetings. The successful candidate will also provide advice and support for feasibility studies and support DMC and CEC management. ...

Requirements:

Job Purpose

This individual will provide medical monitoring for assigned projects. He/She will be responsible for reviewing all documents assigned for scientifically.medically relevant issues, including drug safety. They will function as a medical representative on projects, in the proposal development team and/or in client meetings. The successful candidate will also provide advice and support for feasibility studies and support DMC and CEC management.

Key Accountabilities

  • Answering day to day medical and scientific questions, provide daily medical support to PAREXEL 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 support in preparation of Periodic Safety Update Reports (PSURs).
  • 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 written by PAREXEL 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 PAREXEL departments.
  • Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings)
  • Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
  • 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 PAREXEL personnel, as required.
  • Support Business Development.
QualificationsSkills
  • Experience in clinical practice, with a specialty in Oncology.
  • Experience in Clinical Research/Pharmaceutical medicine desirable but not essential.
  • Excellent interpersonal and communication skills.
  • Client focused approach to work.
Education
  • Medically qualified with completion of training in a clinical setting (internship, residency etc).

Apply for this job: Medical Director (Multiple European Locations Considered)

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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