- Lilly (Indianapolis, IN)
- …batch release. + Provide quality support with a focus on holistic review of manufacturing processes. + Maintain awareness of external regulatory findings affecting ... product quality. + Review and approve documents such as procedures, production records,...systems, regulatory requirements and Commercial GMP + Knowledge of pharmaceutical manufacturing operations. + Demonstrated coaching and mentoring skills.… more
- University of Kansas (Lawrence, KS)
- …, Pharmacology & Toxicology (https://pharmtox.ku.edu/people/list/faculty) , Pharmaceutical Chemistry (https://pharmchem.ku.edu/people/list/faculty) , and Medicinal ... candidates who wish to begin sooner). **Reg/Temp:** Regular **Application Review Begins:** 08-Sep-2025 **Anticipated Start Date:** 05-Jan-2026 **Additional Candidate… more
- Amazon (Severn, MD)
- …assistance and support to operations during life cycle of the data center. - Review results and action items from the quarterly maintenances for BMS and EPMS and ... activities including request for quotation/proposals, responding to request for information, review of vendors proposal and issuance of purchase orders. -… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …across the CMS product portfolio.Responsibilities include assessing need for, creation and review of, as well as implementation of all training materials and ... gap model selling, product competency and commercial management. + Research and review medical articles and studies, general sales training materials and market… more
- Takeda Pharmaceuticals (Boston, MA)
- …the compliance with regulatory agencies and data reporting standards; create and review specifications for SDTM and ADaM datasets as per CDISC IG (Implementation ... Guide); contribute to process improvement initiatives for creating standard outputs; review CRF designs to ensure they meet the protocol criteria, checking… more
- AbbVie (Mettawa, IL)
- …This role is responsible for leading various governance forums, such as Scientific Review Committee (ie, GUS-RC) and Global Evidence Teams (GET) for his/her assigned ... as Operational Lead/Facilitator of research governance teams, such as the Scientific Review Committee (ie, GUS-RC) and Global Evidence Team (GET), including working… more
- Charles River Laboratories (Spencerville, OH)
- …methods and procedures. + Oversee training of clinical pathology technicians. + Review documentation of functions performed as part of quality control requirements. ... + Provide direct daily supervision and review work of assigned departmental employees to ensure accuracy and to ensure adherence to pertinent departmental policies,… more
- System One (Florham Park, NJ)
- …degree preferred. + 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred. + ... PMDA guidances + Performance will be monitored via regular review by the Executive Director and feedback on the...and feedback on the strategist's work. This will include review of meeting minutes, timelines and draft submission packages.… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …execution of existing systems. **Responsibilities:** + Manage, create (vendor) and review ICSR (US/Foreign), PSR reports from clinical and medical standpoint, ... System and achieve compliance with US regulatory requirements + Review current reporting period against historical data to conduct...10+ years in PV & Medical Affairs in the pharmaceutical industry **Skills & attributes:** + Understanding of North… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …budget and timelines from Clinical Study Concept through Final Protocol + Review plans and provision of clinical operations expertise during protocol design, ... + Oversee clinical study budgets within a program: ensures review , presentation and approval of initial study budget and...a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. Does… more