- Johns Hopkins University (Baltimore, MD)
- …held INDs and IDEs in accordance with the JHU governing guideline. The IND /IDE Program Director will develop and maintain all operational functions that support ... IND /IDE activities in the Office of Clinical Trials. These...suitability of a proposed JHU investigator-sponsor for a specific IND /IDE application prior to submission to the FDA ;… more
- University of Colorado (Aurora, CO)
- IND /IDE Office Program Manager - 34555 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Clinical Research and ... Operations Services** **Job Title: IND /IDE Office Program Manager** **Position #: 797456 - Requisition...to initial intake and assessments as required under the IND /IDE program for projects requiring submissions to the FDA.… more
- Walgreens (Indianapolis, IN)
- …nationwide. **Job ID:** 1426916BR **Title:** Certified Pharmacy Technician IND Fulfillment Center **Company Indicator:** Walgreens **Employment Type:** **Job ... Function:** Health Care-Pharmacy **Full Store Address:** 4132 PLAINFIELD RD,INDIANAPOLIS,IN 46231 **Full District Office Address:** 4132 PLAINFIELD RD,INDIANAPOLIS,IN,46231-00000-01399-M **External Basic Qualifications:** + High School Diploma or GED. + Basic… more
- Ricoh Americas Corporation (Philadelphia, PA)
- **Sr Sales Specialist, Commercial & Ind Printing** POSITION PROFILE The Sales Specialist (SS) is focused to driving line of business results through assigned ... strategic Ricoh dealer business partner. This position is field sales execution focused and requires a high degree of business aptitude in direct, channel and integrated solution related sales. The sale of integrated solutions includes the total Ricoh… more
- Alight (IN)
- …Join our team. Because transformation takes a workforce. Learn more at careers.alight.com IND Finance Lead 1: **Contract Management** + Must be able to interpret ... complex contract terms + Able to unpack deal model and enter deal model data into financial tools and tie deal model info back to signed contracts + Create calc tools/forecast files based on client contracts + Maintain SLA Calculations + Aid in contract… more
- Publix (Miami, FL)
- **30326BR** **Position Title:** Maintenance Procurement Coordinator, AM, Ind . Maint. - Miami **Department:** Distribution Maintenance **Location:** Miami, FL ... **Description:** + ordering parts/maintenance materials as needed + procurement of parts through vendor contacts + receiving items/parts in to the parts room + maintaining inventory in parts room + releasing/issuing items/parts and tools from the parts room +… more
- Komatsu (Alsip, IL)
- Chgo Road Ind Trk Mech Jm Date: Sep 28, 2024 Location: Alsip, IL, US, 60803 Req ID: 30951 Onsite or Remote: Onsite Position Komatsu is an indispensable partner to ... the construction, mining, forestry, forklift, and industrial machinery markets, maximizing value for customers through innovative solutions. With a diverse line of products supported by our advanced IoT technologies, regional distribution channels, and a… more
- Signature Aviation (Indianapolis, IN)
- …The following are essential to the job, in addition to those listed above and on the chart in this description. Certain functions may be performed in varying weather ... A Line Service Technician (LST) is a customer service role responsible for a variety of duties that contribute towards safely providing requested services for general aviation aircraft, crews and passengers. An LST routinely operates ground service equipment… more
- Matrix Service (Bellingham, WA)
- …**Job Summary** Work under the direction of a Foreman. Individual must possess a high level of skill in the industrial maintenance/turnaround/construction/or ... mechanical environment. **Essential Functions** + Always represents the Company with high moral standards while adhering to the Company's "Code of Business Conduct and Ethics". + Actively supports the Company's commitment to safety and its "Core Values". +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …and education regarding regulatory requirements, review of FDA submissions for investigator-held IND or IDE research, and review of select protocol and monitoring ... regulatory filings to the FDA (primarily Investigational New Drug ( IND ) and Investigational Device Exemption (IDE) applications). Activities include but… more
- Gilead Sciences, Inc. (Foster City, CA)
- …review, and study archival). + Independently serves as lead study monitor for IND programs, including responsibilities as described above and creating IND study ... timelines, leading resolution of formulation/test material issues, schedule internal/external IND kickoff meetings with Monitors and CROs, coordinate report review… more
- Takeda Pharmaceuticals (Boston, MA)
- …discovery, optimization and progression of programs forward through discovery towards IND . With your experience and expertise in antibody discovery and optimization, ... you will lead biologics programs from early discovery, through candidate selection, to IND and be accountable for the performance and results of a significant… more
- Takeda Pharmaceuticals (Boston, MA)
- …of such methods. Bringing a track record of driving programs to IND with proactive engagement and accountability in program project teams provides the ... + **Program Leader:** + Lead biologics programs from discovery to IND , integrating early research, progression through candidate nomination and selection. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …overseeing all aspects of medicinal chemistry, related to hit identification through to IND filing for small molecule and oligonucleotide therapeutics as well as the ... oncology, neuroscience and gastrointestinal/inflammatory diseases, from hit identification to IND filing; + Dynamically manage the resourcing and prioritization of… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients. + Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations ... to study protocols. + Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other...Assist investigators and study teams in preparing and submitting IND applications to the FDA. + Preparation and submission… more
- Takeda Pharmaceuticals (Boston, MA)
- …on a program-specific basis and timely fulfillment of Pharmaceutical Sciences deliverables to IND . You will also lead late-stage programs as needed. As part of the ... contribute:** + Support the Functional PS-Lead community of preclinical assets up to IND across multiple modalities, therapeutic areas, and regions (US, JP, EU). +… more
- Weill Cornell Medical College (New York, NY)
- …consent documents and other study materials. + Develops, tracks and submits IND /IDE submissions including initial applications, amendments and annual reports to the ... Board and/or scientific review committees. Experience in protocol development and/or FDA IND /IDE submission is desirable but not required. Knowledge of the Food and… more
- University of Pennsylvania (Philadelphia, PA)
- …periods of data lock or in preparation for abstract/manuscript submission. Responsible for IND reporting and/or assisting Sponsor with annual IND reporting. + On ... set-up and execute studies. Be responsible for writing investigator initiated IND /IDE clinical trials in collaboration with faculty supervisor. Speak at investigator… more
- University of Pennsylvania (Philadelphia, PA)
- …for the preparation of health authority submissions including meetings, new IND /IDE applications, and maintenance for these applications by and facilitating all ... for the preparation of health authority submissions including meetings, new IND /IDE applications, and maintenance for these applications by and facilitating all… more
- Frontier Medicines (Boston, MA)
- …enabling project team leads to successfully deliver Development Candidate (DC) molecules to IND and beyond. Requirements What will you be doing? + Interface with CRO ... collaborations and activities to progress compounds from DC to IND and Phase I entry. + Collaborate with management...experience with small molecule drug discovery functions (DC to IND stage) is required. + Experience working in an… more
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