• Eisai, Inc (Nutley, NJ)
    …eTMF internal reviews, reconciliation and study file archival Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the ... folders and trackers for the eTMF, BIMO checklists, study team lists (internal, CRO and vendors), internal study team meetings, country specific documents and all… more
    HireLifeScience (10/17/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in ... works closely with statistical programmers in statistical analyses execution, quality control , and data derivation; collaborates closely with data manager to ensure… more
    HireLifeScience (10/22/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… more
    HireLifeScience (09/27/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… more
    HireLifeScience (09/24/24)
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  • Eisai, Inc (Nutley, NJ)
    …to verify the accuracy of the Datasets created by other programmers or by the CRO . 15%Develop code to verify the accuracy of the results of the summary Tables, ... and Listings created by other programmers or by the CRO . 15%Answer questions from the CRO regarding the study analysis. 15%Participate in study team meetings.… more
    HireLifeScience (11/02/24)
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  • BioAgilytix (San Diego, CA)
    …management, or a related field, with a strong focus on supporting a CRO , CMO, or drug development organization. Working knowledge of selling GMP CMC analytical ... management, or a related field, with a strong focus on supporting a CRO , CMO, or drug development organization.Established sales experience in life science industry… more
    HireLifeScience (10/31/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for ... clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with… more
    HireLifeScience (10/18/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between ... CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for… more
    HireLifeScience (10/18/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM for ... clinical data review activities- May support addressing eligibility and medical questions from sites/ IRBs- May provide medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration… more
    HireLifeScience (09/24/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …implementation of sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for specific categories under ... Years Deep experience in pharma procurement & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated… more
    HireLifeScience (09/24/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for ... clinical data review activitiesMay support addressing eligibility and medical questions from sites/ IRBsMay provide medical guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with… more
    HireLifeScience (09/24/24)
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  • Merck & Co. (North Wales, PA)
    …activities for clinical drug/vaccine projects. May interact with Contract Research Organization ( CRO ).This position may serve as a statistical lead in project teams. ... Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development-Is involved in clinical development planning to ensure that study designs are consistent with… more
    HireLifeScience (11/06/24)
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  • BioAgilytix (Durham, NC)
    …GLP/GCLP quality assurance (QA)Experience working in biotech, pharmaceutical, CRO /CMO or similar organizationMinimum Preferred Qualifications - SkillsInternal and/or ... external GxP auditing experienceAbility to work in fast-paced environment where multiple projects are in process and must be completed in a timely mannerExcellent verbal and written communication skillsAbility to deal effectively with a diversity of… more
    HireLifeScience (11/04/24)
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  • Aequor (Newbury Park, CA)
    …Global Regulatory Plan and provide input to operational deliverables Collaborate with CRO 's / partners to support site initiation Coordinate collection of functional ... documents in support of regulatory filings Participate in GRT to support execution of regulatory strategy Coordinate QC of regulatory documentation (eg briefing materials) Provide primary authorship to routine regulatory correspondence (eg annual reports,… more
    HireLifeScience (11/01/24)
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  • Novo Nordisk Inc. (Los Angeles, CA)
    …A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO , and/or healthcare setting is required A minimum of 2 years of on-site ... monitoring experience is required, however monitoring experience may be waived if relevant Novo Nordisk experience is demonstrated in GCP-related clinical research Bachelor's degree required* (science related discipline preferred): *Alternatively, a Registered… more
    HireLifeScience (10/29/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …with stakeholders to ensure a compliant ready state of operation.Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and CAPAs followed up ... and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision… more
    HireLifeScience (10/23/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …experience in a medical device, pharmaceutical company, or similar environment (eg, CRO ); oncology, immunology, or complex disease therapeutic area is a must. ... Working knowledge of Clinical trial data systems and/or EDC and related applications is a plus required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to… more
    HireLifeScience (10/10/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …review of vendors agreements and policies, external training materials (eg, CRO training materials), study protocols, subject recruitment materials, clinical study ... agreements, research collaboration agreements, informed consent forms or other documentation for clinical trials. Works under supervision to: (1) to respond and defend subject injury claims made against the company, and (2) assist cross functional teams during… more
    HireLifeScience (10/09/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.… more
    HireLifeScience (09/24/24)
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  • Plant Technician- Control Room

    Talen Energy (Baltimore, MD)
    Talen Energy is seeking Plant Technician- Control Room Operator ( CRO ) candidates to join our Operations team at our Brandon Shores power plant, located in ... safe operation. **Skills/Competencies:** 1. Thorough knowledge of all operating duties at control room installations. 2. Must thoroughly understand the function… more
    Talen Energy (11/04/24)
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