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About LanceSoft:
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IT Consulting Services for Government Agencies across 50 states. Is Headquartered in Herndon, VA outside of the DC area.
For details about LanceSoft, click here.
About the Opportunity/Requirements:
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Duration: 12 Months
Description:
The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex development program.
The Project Physician provides active medical and scientific contribution to a cross-functional clinical team developing a new molecular entity currently being studied for central nervous system applications.
Team matrix interactions include project planning, regulatory affairs, data management, medical writing, biostatistics, worldwide medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines.
Responsibilities:
Responsible for medical monitoring/reporting and company 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.
May act as a medical contact at the company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues
Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for FDA submissions
May act, in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees
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 may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
Reviews medical literature and related new technologies
May be asked to assess external clinical research proposals involving company products relevant to company's mission
May be asked to assess medical publications emerging from the Team and its affiliates
The Project Physician develops, in concert with senior clinical staff, credible relationships with opinion leaders, medical directors, and key regulatory officials.
Qualifications:
MD Required. Board Certified strongly preferred
Minimum of 2 years of clinical practice required; and Minimum 3 years industry experience strongly preferred.
Travel up to 20% yearly may be required
Demonstrated expertise creating Phase 3 protocols and performing safety oversight for ongoing trials required.
Special Note:
A major portion of this job will be directly interacting with sites regarding questions of eligibility and safety.
They must have clinical practice experience and medical license.
They will need to be available by phone to accommodate calls from sites throughout the U/S. and Canada.
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