• 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
    HireLifeScience (05/17/24)
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  • 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
    HireLifeScience (04/06/24)
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  • Lundbeck (Boston, MA)
    …connects KOLs and external stakeholders internally to serve as advisors, investigators , expert consultants, authors, or evidence generation partners Executes on MSL ... gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request,… more
    HireLifeScience (06/01/24)
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  • Taiho Oncology (TX)
    …cancer treatment evolves, we evolve with it. Advanced technology, dedicated investigators , and incomparable facilities: these vast resources empower us to redefine ... clinical, scientific and medical information between Key Opinion Leaders (KOLs)/ investigators and the company's Medical Affairs and development groups. Establish,… more
    HireLifeScience (05/09/24)
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  • Lundbeck (Miami, FL)
    …connects KOLs and external stakeholders internally to serve as advisors, investigators , expert consultants, authors, or evidence generation partners Executes on MSL ... gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request,… more
    HireLifeScience (04/22/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all ... of clinical trials improvement/innovation projects for NACD & Novo Nordisk (eg Investigators and site staff, vendors etc.). Establish and manage senior level… more
    HireLifeScience (05/16/24)
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  • 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
    HireLifeScience (05/28/24)
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  • Merck & Co. (Rahway, NJ)
    …approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external ... agencies and investigators .Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or… more
    HireLifeScience (05/22/24)
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  • Daiichi Sankyo, Inc. (Nashville, TN)
    …medical informationIdentifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research ... programs, 2) investigator -initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing… more
    HireLifeScience (05/22/24)
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  • 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
    HireLifeScience (05/21/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …in conjunction with Medical Writing- Leads scientific components of IM ( Investigators Meeting) and SIV (Site Initiation Visit) Training: compound, Diagnosis (Dx) ... and CSR safety narratives- May lead the development and updates of the Investigator 's Brochure (IB): author the clinical section and lead the development of the… more
    HireLifeScience (05/15/24)
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  • Merck & Co. (North Wales, PA)
    …scientific findings, research methodologies-Identification of scientifically and operationally strong investigators who can assist in the development of our ... company's investigational and marketed drugs-Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those… more
    HireLifeScience (05/30/24)
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  • Merck & Co. (Rahway, NJ)
    …scientific findings, research methodologies;Identification of scientifically and operationally strong investigators who can assist in the development of our ... companies investigational and marketed drugs;Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those… more
    HireLifeScience (05/30/24)
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  • Merck & Co. (Rahway, NJ)
    …scientific findings, research methodologiesIdentification of scientifically and operationally strong investigators who can assist in the development of our company's ... investigational and marketed drugsEstablishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who… more
    HireLifeScience (05/29/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the internal clinical study physicians and physician scientists as well as external investigators is expectedThe CS Group Lead will also ensure the writing of ... ethical and regulatory requirements across regions- Interact with clinical investigators , academic organizations, co-development partners, and strategic outsourcingCS Group… more
    HireLifeScience (05/16/24)
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  • Novo Nordisk Inc. (Milwaukee, WI)
    …support in cooperation with other Novo Nordisk groups to ensure investigators demonstrate appropriate knowledge of studies, support patient recruitment and retention ... activities, answers responsive requests from investigators and provides feedback to sites to other groups Coordinates and collaborates with regional FMA team members… more
    HireLifeScience (05/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …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 ... Subject Protection (January 2009) o FDA Guidance for Industry and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan… more
    HireLifeScience (04/12/24)
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  • Merck & Co. (North Wales, PA)
    …preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator 's brochures, clinical sections of submissions) per company and ... a subset of clinical regulatory documents (eg, clinical study reports, investigator 's brochures, clinical sections of submissions) per regulatory requirements and… more
    HireLifeScience (05/24/24)
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  • 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
    HireLifeScience (05/22/24)
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  • 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
    HireLifeScience (05/18/24)
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