- Pfizer (Groton, CT)
- …safety assessment of pharmaceutical drug candidates in compliance with GLP regulatory standards as applicable within a DSRD Clinical Pathology Laboratory. ... + Perform all regulatory responsibilities in compliance with applicable regulatory standards as applicable within a DSRD Clinical Pathology Laboratory +… more
- Abbott (Maple Grove, MN)
- …/ Clinical Evaluation Reporting (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise ... and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related… more
- Insight Global (Beachwood, OH)
- …and manage regulatory applications (FDA and other global agencies). - Clinical Execution & Oversight o Oversee clinical study activities including site ... and study closeout. o Ensure studies are conducted in compliance with approved protocols, regulatory standards, and... records. o Author or support the development of clinical study reports, white papers, and regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory ... user needs into technical requirements + Coordinate risk mitigation activities across clinical , regulatory , quality, and engineering functions + Perform safety… more
- J&J Family of Companies (Titusville, NJ)
- …management, finance, legal, quality assurance, quality monitoring & compliance , clinical supplies unit, TA strategy, regulatory affairs, data management, ... trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory...including Excel and Word** **Experience and knowledge of Good Clinical Practices and regulatory requirements for the… more
- Abbott (Plymouth, MN)
- … clinical evidence. This evidence will establish feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and ... 114,000 colleagues serve people in more than 160 countries. **Senior Manager, Clinical Research** **About Abbott** Abbott is a global healthcare leader, creating… more
- Abbott (Santa Clara, CA)
- …scientific literature, analyzing scientific data and staying abreast of current clinical practice. + Facilitates regulatory submissions and communications by ... deliverables. + Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance… more
- University of Michigan (Ann Arbor, MI)
- …actions to minimize risks + Explains and performs study operational activities in compliance with Good Clinical Practice (GCP) + Explains proper documentation ... Clinical Research Technician / Assistant Apply Now **Job...ability to anticipate and mitigate the potential for protocol non- compliance . + Describes protocol structure and explains how to… more
- Teleflex (Minneapolis, MN)
- …on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, ... projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical , Regulatory , Sales, and clinical site staff as… more
- Cedars-Sinai (Los Angeles, CA)
- …engagement, survey and interview administration, data collection and management, ensuring compliance with regulatory requirements, and contributing to the ... protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the… more