Technical Resources International, Inc. Jobs in United States

Oversight of clinical operations activities including one or more of the following: clinical project management, clinical site management and/or clinical systems management with an understanding and working knowledge of regulatory data management analysis and scientific technical ...

This position involves preparing regulatory documentation and maintaining filing systems. · ...

Design and develop training plans including learning objectives. · ...

Prepares scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) etc. · ...

Prepare regulatory submissions including drug and biologic Investigational New Drug Applications INDs Biologics License Application BLAs New Drug Application NDAs Investigational Device Exemption IDEs ensuring compliance in accordance with GCPs ICH and all applicable FDA other Re ...

+Oversight of clinical operations activities. · +Suports one or more government or commercial contracts. · Responsible for project management oversight for multiple functional areas. · ...

Supports the maintenance and upkeep of the Quality Management System (QMS). · Maintains the Quality Assurance (QA) training program · document control · deviation program · ...

Creation and ownership of risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials. · ...

+ Prepare standard documentation supporting regulatory filings and distribution to stakeholders. · + Responsibilities · Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate. · ...

Perform needs assessments and design and develop training plans. · ...

Maintains the Quality Assurance (QA) training program and document control. · ...