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Senior Director Clinical Research Gastroenterology Job
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| Employer Name: HealthcareCrossing |
SpiderID: 2380520 |
| Location: Chesterbrook, Pennsylvania |
Date Posted: 7/19/2008 |
| Wage: |
Category: Healthcare |
| Job Code: |
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Job Description:
Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. The Senior Director Clinical Research will be responsible for the development and execution of clinical programs for company products. He/She will be responsible for study design, protocol development and execution of clinical studies. Acts as a liaison between company and clinical investigators. The Director develops credible relationships with opinion leaders, medical directors, and key regulatory officials. Responsible for medical monitoring/reporting and company safety officer activities. Evaluates adverse events (pre and post-marketing) for relationship to treatment. Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting. Acts as medical contact at company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues. Interprets, reports and prepares oral and written results of product research in preparation for FDA submissions. Assists Regulatory Affairs in the development of drug/device regulatory strategies. Acts as company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees. Creates clinical education and support programs. Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities. Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance. Participate on cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
For more information, please click here to visit us at HealthcareCrossing
For further information, please visit us online at http://www.healthcarecrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: HealthcareCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.healthcarecrossing.com
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