Job Search Results - Biospace
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Technical Resources International Inc.
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Your search returned 16 jobs



9/20/2016
Technical Resources International Inc.
Bethesda, MD

Process/evaluate serious adverse event reports for developmental & marketed compounds; Prep case safety reports for review & submission to reg auth; Perform med qual ctrl of processed IND Safety Reports, MedWatch Reports & SAE reports; Review...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

This position is part of a team supporting government-sponsored clinical trials. The key responsibilities include: • Draft pre-IND packages, FDA correspondence, and other regulatory submissions in support of active and planned investigational...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

Responsibilities: •Managing the lifecycle of investigational applications (INDs, NDAs, BLAs, IDEs, etc.) and ensure compliance in accordance with GCPs/ICH and all applicable FDA regulations. •Preparing scientific and regulatory documents (e.g....

9/20/2016
Technical Resources International Inc.
Bethesda, MD

The key responsibilities include: •Overseeing and managing electronic regulatory submissions in support of active and planned investigational applications (INDs, NDAs, BLAs, IDEs, etc.) •Applying knowledge of electronic publishing requirements to...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

TRI is currently seeking a Regulatory Associate who is a team player to join our Bethesda, MD group. Responsibilities: •Prepare standard documentation supporting regulatory filings •Maintain files for regulatory documents •Maintain and update...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

This position involves assistance to the Quality Assurance Department to ensure that TRI meets client, regulatory, and statutory requirements as it relates to its quality management system. Primary responsibility is to maintain Trackwise in the...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

Responsibilities will include: •Coordinating, attending, and, at times, leading conference calls/meetings related to clinical trials. •Preparing meeting minutes/action items and distributing these to meeting participants. •Preparing, or assisting...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

Primary responsibilities include applying the ADDIE model to design and develop effective training programs. Conducts needs assessments. Develops training plans to include learning objectives, target audience, course outlines, case studies,...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

This position will review and process essential regulatory documents received from clinical trial sites; request additional information when necessary; respond to protocol and process-related queries; maintain trial master files, and track the...

9/20/2016
Technical Resources International Inc.
Bethesda, MD

Human Subject Protection Specialist - Clinical Research This position will act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research. Responsibilities...