- Parexel (Indianapolis, IN)
- …Regulatory Authority meetings) **Literature review (as applicable)** + Review of literature for product safety assessment and potential safety issues + ... therapeutic area training), as requested, at internal and external meetings (such as investigator meetings) + Provide medical safety expertise to client per… more
- Parexel (Indianapolis, IN)
- …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
- Parexel (Indianapolis, IN)
- …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
- Lilly (IN)
- …protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator /site management). + ... trials, the reporting of adverse events as mandated by corporate patient safety ; the review process for protocols, study reports, publications and data dissemination… more
- Lilly (Indianapolis, IN)
- …Oversee local safety monitoring and adverse event follow‑up. + Review investigator ‑initiated trial (IIT) proposals as needed. + Ensure global alignment of Phase ... Unit - Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence… more
- Lilly (Indianapolis, IN)
- …Business Unit is focused on scientific and medical expertise to support product launch, commercialization, and the patient journey. Key responsibilities include: - ... trials in local affiliates/countries. - Ensuring regulatory compliance and safety reporting. - Supporting pricing, reimbursement, and access (PRA) strategies.… more
- Lilly (Indianapolis, IN)
- …clinical trials in support of registration and commercialization of the product ; the implementation of global clinical trials; the reporting of adverse ... events as mandated by corporate patient safety ; the review process for protocols, study reports, publications and data dissemination for products, new and updated… more
- Lilly (Indianapolis, IN)
- …clinical trials in support of registration and commercialization of the product ; the implementation of global clinical trials; the reporting of adverse ... events as mandated by corporate patient safety ; the review process for protocols, study reports, publications and data dissemination for products, new and updated… more
- Lilly (Indianapolis, IN)
- …Early Phase / Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical ... the reporting of adverse events as mandated by corporate patient safety ; review process for protocols, study reports, publications and data dissemination… more
- Lilly (IN)
- …the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the ... management, as well as other duties as assigned. + Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design.… more