|
|
|
|
| Employer Name: BiotechCrossing |
SpiderID: 2355130 |
| Location: Bridgewater, New Jersey |
Date Posted: 7/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5975561 |
|
Job Description:
STUDY MANAGEMENT TEAM (for Assigned Product(s)o Review, approve and supervise all aspects of US phase clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, and clinical trial guidelineso Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations Ensure final accuracy of clinical trials data and its timely availability (Clinical Study Report), in appropriate format and works closely with Regulatory in developing plans for IND and/or s submissions (Medical Representative)o Medical review and approval of promotional material (including concepts) in compliance with corporate standards and government/industry regulations.Provide medical support to product planning and Life Cycle Management groups on the impact of line extensions, new indications, formula changes, opinion leader development and publication strategies for products/therapeutic area products- Work with global colleagues to ensure consistency of worldwide programs from a medical perspective- Support product information letters/responses and medical education processes (CME grants)- Provide medical review and approval of regulatory documents pertaining to the work of the medical team - Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals.- Provide medical input to the product labeling, as needed- Provide professional medical expertise to Sales, Marketing and Legal functions on marketed products and drugs currently in approval process- Assure alignment of initiatives across any existing Joint Ventures, including design and execution of all strategies and programs- Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community.
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
Sign Up Now
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
|
|
|
|
|
|
|