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| Employer Name: BiotechCrossing |
SpiderID: 2212538 |
| Location: Jacksonville, Florida |
Date Posted: 5/3/2008 |
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Category: Biotech |
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Job Description:
The primary responsibility for this position is to design and manage pre-clinical and clinical studies to support development, regulatory approval, and post-market surveillance of innovative new products that anticipate the needs of our customers. This includes preparation and management of the annual research budget (approximately $1.4M annually), design of study protocols, preparation and negotiation of research contracts, management of compliance to study milestones, evaluation and analysis of study results, and assisting with regulatory document preparation and management of clinical research organizations. The secondary responsibilities for this position include: management of wet lab facilities, chairing monthly Research Committee meetings with upper management, and management/development of one direct report (administrative assistant). Requirements: Pre-clinical and clinical research experience (5 years minimum) Statistical analysis experience for protocol development and study result evaluation Involvement in at least one clinical trial to support a PMA/IDE submission to FDA Knowledge of ISO 13485 requirements Travel: 20% Education: Bachelors Degree in Engineering, Biomedical, Biochemistry, or Public Health - Epidemiology disciplines Excellent Problem Solving Skills, Conflict Resolution Strong interpersonal skills Business acumen, strategic thinker High energy & persistent, results oriented Excellent Communication Skills.
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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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