Director, Medical Leader Job

Employer Name: BiotechCrossing	SpiderID: 2200955
Location: Raritan, New Jersey	Date Posted: 4/23/2008
Wage:	Category: Biotech
Job Code:

Job Description:

Assists Regulatory Affairs in the development of worldwide 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 and lead cross-functional teams for evaluation of new product ideas, implement franchise strategies, etc. Reviews medical literature and related new technologies. Responsible for assessment of external clinical research proposals involving company products relevant to company's mission. The essential functions in this role include responsibility for design and implementation of clinical trials and for the content of clinical study reports . Assists in Interpreting, reporting and preparation of results of product research in preparation for world-wide health authority and FDA submissions. Responsible for medical monitoring/reporting and 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 worldwide health authorities concerning clinical/medical issues. Assists Regulatory Affairs in the development of drug/device regulatory strategies.

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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

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com