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Regulatory Affairs Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2221082 |
| Location: San Antonio, Texas |
Date Posted: 5/12/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Ensures appropriate reporting of clinical trial adverse and serious adverse events to the appropriate global regulatory agency. * Develops adverse event or incident reporting procedures using regulatory requirements for each country. Utilizes electronic or hardcopy methods to complete and submit reports to the appropriate global regulatory agency or body. * Collaborates with APAC, EMEA, and Americas Regulatory Affairs Directors to obtain information regarding potential adverse events. Also utilizes resources from Quality Assurance Complaint Handling to obtain incident information. * Design and maintain databases that allow for the tracking of adverse events for all products in regards to wound type and care setting. * Utilize adverse event tracking and trending information for updates provided to senior management. * Organize and lead adverse event review meetings with Quality Assurance, Medical, Compliant Handling, and Engineering in order to determine reportability of events. * Collects and analyzes information regarding incidents that are potentially reportable in the countries where KCI markets its products. * Actively participates and oversees the review of adverse event information in accordance with written procedures and policies to determine if an incident is reportable to the appropriate global regulatory agency. Filing decisions are documented and reported. * Prepares and submits incident reports to the appropriate regulatory agency and body. Assures compliance for safety data reporting. * Participate in corrective action activities in terms of providing trending information regarding adverse events. * 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.
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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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Web Site: http://www.biotechcrossing.com
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