- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …direct/indirect referral: Incumbent will have mix of direct and indirect-matrixed investigators as subordinates Essential Functions Assess the current state of ... and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator … more
- Taiho Oncology (New York, NY)
- …updated clinical, scientific, and medical information between Scientific Leaders (SLs)/ investigators , and the company's Medical Affairs and development groups. ... collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review… more
- Eisai, Inc (Nutley, NJ)
- …coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing, ... professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE's from clinical trials. 30%Assist… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …(eg, Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by ... medical informationIdentifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the ... as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory inspection… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …budget expenditures as directed Records all activities within a customer response management system (eg VEEVA) and all expenses within Concur in accordance with FMA ... support in cooperation with other Novo Nordisk groups to ensure investigators demonstrate appropriate knowledge of studies, support patient recruitment and retention… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and their importance / relevance to key constituents, information stewards, system owners, stakeholders, and data users.- Collaborate with an extensive cross ... Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators , Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited… more
- BioAgilytix (Boston, MA)
- …Watson LIMS or automation; liaise with all parties to promote adoption of systems for increased efficiency Creates and manages system Standard Operating ... responsibilities of a traditional lab analyst, peer reviewer, and new system implementation specialist. Tasks will encompass running assays, reviewing data, and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …a variety of animal models of disease; and may serve as the principal investigator or study director on a variety of sponsored programs; supervise and oversee the ... of disease models and safety/efficacy studies; support and develop investigator -initiated sponsored research programs; and perform all other related duties… more
- Eisai, Inc (NJ)
- …clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing ... improving medical writing capabilities within own area by improving systems / tools and providing trainingMonitoring and evaluating project metrics, escalating… more
- Tris Pharma (Monmouth Junction, NJ)
- …implementation and maintenance of a highly compliant, effective and ethical PV system Participates in drafting and implementation of PV contracts, agreements and ... to safety sections of key study documents such as (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study… more
- Catalent (Philadelphia, PA)
- …dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, ... "Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution, returns,… more
- Eisai, Inc (Nutley, NJ)
- …vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility; identifies ... disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the… more
- Eisai, Inc (Nutley, NJ)
- …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the… more
- Eisai, Inc (Nutley, NJ)
- …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the… more
- Catalent (Philadelphia, PA)
- …dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, ... and SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record documentation and support Problem… more
- Aequor (NJ)
- …clinical supply processes to facilitate improved cross-functional relationships. Speaking at Investigator Meetings as required. Traveling as required ( Writing of / ... of import / export requirements. Proficient/Strong knowledge of IRT and CTMS systems . Proficient / Strong knowledge of industry technology. Applies and drives… more
- Ventura County (Ventura, CA)
- …The Bureau is staffed with a chief investigator , a deputy chief investigator , 3 commanders, 8 supervising district attorney investigators , district attorney ... District Attorney Investigator I/II Print (https://www.governmentjobs.com/careers/ventura/jobs/newprint/4165939) Apply District Attorney Investigator I/II… more
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