- 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
- Insmed Incorporated (San Diego, CA)
- …projects.Manage and participate in developing and drafting protocols, forms, investigator brochures, clinical study reports and other documents as needed.Manage ... and development of systems , practices, and procedures to ensure efficient and effective...management and analysis.Build and maintain relationships with KOLs and investigators to foster strong partnerships.Develop and maintain appropriate metrics… more
- Merck & Co. (Rahway, NJ)
- …in a timely manner in coordination with the study CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial ... in and excellent working knowledge of core trial management systems and toolsBehavioral Competency Expectations:High emotional intelligenceStrong leadership skills… 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
- Daiichi Sankyo, Inc. (Louisville, KY)
- …(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. (New York, NY)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …clinical trial result reportingLeads interactions with academic thought leaders, investigators and other clinical stakeholders; Represents Company and its programs ... Key Opinion Leaders (KOLs), scientific advisory boards and lead clinical investigators , among others Advises Senior Leadership on clinical development matters,… 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
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