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Regulatory Affairs Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2214581 |
| Location: San Antonio, Texas |
Date Posted: 5/6/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Provides analysis of adverse event information to support new product or new product claim. * Assists with the design, planning, and implementation of clinical trials, as well as the management and coordination of regulatory project activities associated clinical studies. * Reviews clinical study summary reports and interim data analyses to ensure that clinical results meet the requirements of regulatory agencies and other product approval authorities for adequacy and integrity. * Assists with preparation for and participate in regulatory agency audits. * Assists with preparing documentation, primarily investigators\' brochures, clinical study reports, annual protocol reports and manuscripts for submissions for new product or new intended uses for existing products in support of domestic and international product marketing approvals. * When applicable, participates in clinical trial activities, such as investigator meetings, study initiation, ongoing monitoring, and close-out visits. * Assists with the writing, review, and revision of regulatory and clinical study SOPs. * Effectively manages projects by establishing project timelines to ensure effective resource management and to facilitate project review. * Reviews labeling, product and process changes, and product documentation as it pertains to global product surveillance and clinical trials. * Participates in internal regulatory training for KCI departments. * May supervise one or more Regulatory Affairs Specialists. Successful management of people and projects is essential. Excellent communication, negotiating and influencing skills are required.
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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: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.biotechcrossing.com
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