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Job Title: Regulatory Affairs Consultant - Clinical Trials
Job ID: Job-C-0296
Job Location: Washington, DC, 20001
Salary: $100K-$175
Job Description: Our client is a prestigious consulting firm with a business unit focusing on the life sciences industry and government agencies markets
They provide technical, regulatory, manufacturing and operational improvement services across the entire pharmaceutical/biopharmaceutical industry from discovery through commercialization.
Approximately 5 years ago they added consulting offering within the critical life science and biomedical R&D segments of the federal government. As pandemic disease preparedness and bioterrorism became ever more critical issues, our client has increasingly worked with the Department of Homeland Security and Department of Defense.
This role will offer a significant exposure to other high-level individuals both within private industry and the US Federal Government which will prove highly valuable to your future career.
Position Overview
You will provide subject matter expertise in the assessment of regulatory submissions with meticulous contribution regarding clinical study aspects of contracted activity. Key responsibilities include:
• Assisting in identifying deficiencies or problems regarding clinical issues prior to submission to the FDA.
• Reviewing and assessing product development related documentations, presentations and meeting proceedings to provide regulatory issue input during the entire product development process - with particular emphasis on clinical study-related activities of BARDA contracted activities.
• Providing clinical study subject matter expert advice and guidance on dealing with regulatory and or quality assurance issues involving the contracted countermeasure sponsor, the FDA, CDC, NIH and DoD cooperative projects, including meeting proceedings and possible site visits/audits ("inspections").
• Interface in some instances with relevant FDA Centers regarding clinical studies aspects of the investigational, advanced development, approval, and post-marketing phases of counter measure development.
• Conducting site visits, as needed, in accordance with FDA regulations and FAR/HHAR regulations, pertaining particularly to aspects of product clinical development, including but not limited to clinical study planning design, execution and reporting and post approval regulatory requirements.
What you will need:
Masters, M.D., Ph.D. or PharmaD and a minimum of 5 years of experience in FDA regulated drug, medical device and/or biologics industry including significant experience directly involved with human clinical trials.
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