• Merck & Co. (Rahway, NJ)
    …and to improve outcomes for patients.The EDSA leads a large investigator -initiated studies program in partnership with late-stage development teams in Medical ... comprehensive Congress summary reports. Primary Responsibilities: Leads our Company's Investigator Initiated Studies program for our cardiovascular portfolio (Atherosclerosis,… more
    HireLifeScience (03/14/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …of investigators for clinical studies and provide medical support to investigator meetings Provide protocol training, disease specific training and titration ... and/or review clinical sections of clinical trial reports, statistical reports, investigator 's brochures, INDs, NDA and responses to Regulatory questions Provide… more
    HireLifeScience (03/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgets.Collect ... to supervisor's attention.Track study metrics such as site start-up, Investigator /site performance, recruitment, regulatory documents, TMF filing and QC activities… more
    HireLifeScience (03/09/24)
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  • Merck & Co. (North Wales, PA)
    …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The RMSD serves as a role model for ... the comprehension of the scientific foundations and goals of investigator -sponsored researchIdentifies barriers to patient enrollment and retention efforts to… more
    HireLifeScience (03/08/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator -initiated studies (IIS) as part of a Global IIS Review Committee, for ... engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key… more
    HireLifeScience (02/23/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Safety Scientist Lead and PSL to author safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet ... (CCDS), Risk Management Plan(s) (RMPs)- Contributes to regulatory authority requests or communication for assigned clinical studies- CTD submissions/Others- May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …of, support to, and follow-up of audits and inspections Monitoring of the Investigator Portal for, and Central IRB/REB submission of, SUSARs for assigned clinical ... trials, including distribution of SUSARs to clinical trial sites Maintenance of systems, eg, CTMS, eTMF and set up of study email/mailboxes Identification of problems in relation to tasks and key deliverables and mitigate accordingly with guidance from the… more
    HireLifeScience (03/26/24)
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  • Taiho Oncology (TX)
    …In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP initiated projects. Facilitate the review ... and follow-up of submitted IITs. Assist with Taiho sponsored trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and communication of scientific insights for… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …up to 2 years of experience 5+ years of experience as an investigator in the EEO, Anti-Harassment or Anti-Discrimination space is required Prior experience managing ... a team is preferred Demonstrated acumen in data analysis and data reporting is strongly preferred Knowledge of federal and state laws, regulations and industry guidance applicable to the EEO space is required Handles confidential information with discretion… more
    HireLifeScience (03/21/24)
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  • BioAgilytix (Durham, NC)
    …needs based on projected project needsMay serve as principal investigator on a projectMay prepare and submit deviationsManage project timelines/schedulingManage ... budget and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assay independentlyAbility to assist with definition of project scope and proposal preparation (SME)Prepare and review scientific training materialsSet up studies in… more
    HireLifeScience (03/15/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD ... submissions, and responses to questions from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of… more
    HireLifeScience (03/12/24)
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  • Insmed Incorporated (San Diego, CA)
    …of site and team training plans.Plan and/or participate in investigator meetings, kick-off meetings, monitoring training, and various vendor meetings.Participate ... in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.Present trial status and clinical operations strategy to project team and management.Create and/or review and approve study documents, eg,… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …development of local data generation study concepts and protocolsReviews Investigator -Initiated Study proposals from key countries prior to headquarters submission ... (ex-USA)Manages programs (patient support, educational or risk management) to support appropriate and safe utilization of Our Company medicines or vaccines Required Qualifications, Skills & Experience: Minimum: MD, Ph.D. or Pharm.D. (MD preferred) and… more
    HireLifeScience (03/08/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …(TLF) 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 ... other sections in collaboration with the other authoring functions.Accountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol,… more
    HireLifeScience (03/07/24)
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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, ... tracking and distribution; Interact with health professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE's from clinical trials. 30%Assist in projects requiring review and assessment of… more
    HireLifeScience (03/05/24)
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  • Tris Pharma (IL)
    …with ongoing and planned clinical trials and supports the evaluation of Investigator Initiated Research proposals as appropriate Participates in development of a ... customer-centric tactical medical engagement plan to support Medical Affair’s strategies including: - Contributes to the development of a regional specific medical engagement plan for scientific exchange with prioritized stakeholders in support of Medical… more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Philadelphia, PA)
    …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 advisory boardsGathering customer insights regarding DSI and competitor products to help inform medical and commercial decision makingEnhanced professional expertise through attendance of select scientific… more
    HireLifeScience (02/24/24)
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  • Lovelace Biomedical Research Institute (Albuquerque, NM)
    …(MRI) environment. The postdoctoral fellow will work closely with the Principal Investigator to complete project analyses and publish the findings in peer-review ... journals.QualificationsRequires a Ph.D. or MD in a directly related field, and a proven record of peer-reviewed publications including demonstrated first-authorship success in applicable research areas.The successful candidate will have demonstrated… more
    HireLifeScience (02/22/24)
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  • Eisai, Inc (Nutley, NJ)
    …advisory boards, health outcomes plans, MSL activities, speaker programs, investigator -initiated research and CME grant reviews or other internal key ... business processes. Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.External leadership: Provides leadership and strategic direction to… more
    HireLifeScience (02/14/24)
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