- AbbVie (North Chicago, IL)
- …to safety questions from investigator sites and IRBs regarding safety issues and queries. Post-market/ Product Surveillance Safety + Ensure ... communicate safety issues. May contribute relevant clinical safety input to new product design teams...based on the clinical study requirements. + Responds to safety questions from investigator sites and IRBs… more
- Parexel (Springfield, IL)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP),… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF). * Conducts Investigational Product (IP) review and ... and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan. * Monitors data,… more
- Abbott (Abbott Park, IL)
- …Boards, and product summits. + Engaging with customers on device efficacy, safety , and future product development needs. + Training and supporting US ... + Collaborate with R&D, manufacturing, and quality teams to integrate product lifecycle insights into clinical trials; align clinical strategies with commercial… more
- Sanofi Group (Chicago, IL)
- …Business Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and ... to enhancement of Sanofi's scientific messages, plans, strategy, systems, and product development. + Maintain awareness of and assesses emerging evidence in… more
- Parexel (Springfield, IL)
- …various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks. **Key ... etc.) + Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country...of monitoring + Supports the CRA to develop positive Investigator relationships throughout the life of the study and… more
- Merck (Springfield, IL)
- …organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, ... Quality (CQ) provide independent assurance that our Company ensures the safety , rights, and well-being of participants, while complying with applicable global… more
- Pfizer (Lake Forest, IL)
- …and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk ... clinical trial data. + Review and approve submission level safety narrative plan. + Supports product label...submission level safety narrative plan. + Supports product label development and maintenance. + Engage key external… more
- AbbVie (Mettawa, IL)
- …they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient's journey. The Scientific Director, Medical Affairs ... educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance… more
- AbbVie (Mettawa, IL)
- …(medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities and safety surveillance activities). ... with commercial teams to provide strategic medical input into core brand ( product ) strategies, and to support medical and marketing activities (promotional material… more