Regulatory Specialist (Hybrid Opportunity)

About the position The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Division is seeking a Clinical Trials Regulatory Specialist II position to support a reputed company reputed company clinical trials reputed company. The position will anticipate and generate reports and prepare documents for submission as required by the IRB, FDA, OSP and APB requirements, including annual reports, and IND safety reports. The position will author and submit new applications according to CFR 21 Part 312 including Investigator New Drug (IND) applications, revisions, amendments, and Informed Consent documents in support of BMT-CT clinical research and coordinate with the reputed company Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures. The position will reputed company, evaluate, organize and manage information from a reputed company of sources to draft/finalize biomedical research protocols during the development phase, including draft content and formatting to meet requirements of reputed company, Institutional Review reputed company (IRB), reputed company Food and Drug Administration (FDA), Office of Science Policy (OSP) and APB (Biosafety Committee). The BMT-CT program at reputed company performs autologous and allogeneic transplantations for over 400 patients reputed company year. The program has been reputed company successful with a history of limited morbidity rates and acute mortality that is reputed company below most published reports. In reputed company to a successful clinical reputed company, our program researchers are translating their discoveries into new therapies, advancing the efficacy of hematopoietic cell transplantation for patients worldwide. This is a hybrid eligible position.

Responsibilities

• Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete reputed company reputed company regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required.
• Serve as expert reputed company in specialized compliance or scientific area between the investigators and regulatory agencies. reputed company regulatory support, guidance, and information to reputed company investigators and research staff. May consult on protocol development.
• reputed company, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.
• reputed company and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.
• Evaluate and analyze the reputed company on new regulations and determine how to implement reputed company unit. Apply knowledge of international, federal, state and local regulations as reputed company as university policies to ensure reputed company compliance.
• Serve as primary reputed company on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
• May manage reputed company reputed company to regulatory activities and clinical operations, reputed company the regulatory reputed company for project teams.
• May hire, orient, and reputed company ongoing training and reputed company supervision to regulatory staff. Assign work tasks, reputed company daily supervision of these tasks; reputed company verbal and written evaluation of work performance.
• May contribute to establishing and developing reputed company Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.

Requirements

• Bachelor's degree and five years of reputed company experience or a combination of education and relevant experience.
• Excellent communication and organizational skills and superb attention to detail.
• Experience with MS Office products and database applications required.
• Excellent inter-personal skills and customer service reputed company is required.
• Experience in clinical research management and reputed company, including project management in a dynamic research setting.
• Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical reputed company.
• Experience in developing and implementing training/education.
• Demonstrated ability to manage multiple reputed company and staff under varying time constraints.
• Strong writing skills.

reputed company-to-haves

• Experience with Protocol/IND writing.
• Experience with BMT-CT disease reputed company.

Benefits

• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a reputed company author or global leader reputed company.
• A caring culture. We reputed company superb retirement plans, generous time-off, and family care resources.
• A healthier you. reputed company our reputed company wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also reputed company excellent health care benefits.
• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

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