• 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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  • 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 ... considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and… more
    HireLifeScience (06/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect… more
    HireLifeScience (06/06/24)
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  • Catalent (Philadelphia, PA)
    …employee safety, will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer satisfaction and ... projects and/or tasks and ensuring that all functions are being performed in compliance with SOPs. This is a full-time position: Monday - Friday, days. Catalent… more
    HireLifeScience (06/08/24)
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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 ... oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work… 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 ... oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within… more
    HireLifeScience (05/18/24)
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  • Merck & Co. (Rahway, NJ)
    …with Global Clinical Trial Operations to support continuous process improvement and compliance in the spirit of what is best for the business.Track inquiries ... review/approval.Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GSBP management as well as our company's… more
    HireLifeScience (06/08/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …with operational deviations and a champion for quality priority principles and compliance within the organization. This is an onsite based role with relocation ... 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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  • 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.Continuously ensures compliance with Eisai policies and procedures for all activities undertaken and monitors various government and industry… more
    HireLifeScience (06/08/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program ... including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD… more
    HireLifeScience (06/07/24)
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  • Eisai, Inc (Nutley, NJ)
    …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... of coding practices among International offices.Interface with Clinical for investigator training Essential Functions Adverse event information collection, processing,… more
    HireLifeScience (05/28/24)
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  • Lundbeck (Boston, MA)
    …gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request, ... training, documentation, expense reporting, and other administrative responsibilities Ensures compliance with all FDA and Lundbeck requirements REQUIRED EDUCATION,… more
    HireLifeScience (06/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... such as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities in order… more
    HireLifeScience (05/24/24)
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  • Eisai, Inc (Nutley, NJ)
    …expected to be a team player, and an advocate for quality, compliance , professionalism, and core corporate values at Eisai. Essential Functions Conceptualization, ... and vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility; identifies… more
    HireLifeScience (05/28/24)
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  • Merck & Co. (Rahway, NJ)
    …the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the ... approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external… more
    HireLifeScience (05/22/24)
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  • Taiho Oncology (New York, NY)
    …collaboration with Medical Affairs personnel supports data generation in Investigator -Initiated Trials (IITs) and SL/HCP initiated projects. Facilitates the review ... Medical Affairs Department and Taiho organization, including as it pertains to compliance with policies, systems and practices. Possesses and maintains a valid… more
    HireLifeScience (05/21/24)
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  • BioAgilytix (Boston, MA)
    …Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of data and documentation generated by the Bioanalytical Operations ... by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator )independently creating reports, plans, and submission documents in support of… more
    HireLifeScience (05/03/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes to ... safety sections of key study documents such as (ie, Investigator Brochures, protocols, statistical analysis plans, informed consent forms, Clinical Study Reports… more
    HireLifeScience (04/05/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and other cross-functional and regional stakeholders. Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... slide decks, and other internal training resources, within legal and compliance regulations. Provides training or communication of emerging data (internal or… more
    HireLifeScience (04/30/24)
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  • Lundbeck (Miami, FL)
    …gaps Identifies and facilitates the submission of grant requests and investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request, ... training, documentation, expense reporting, and other administrative responsibilities Ensures compliance with all FDA and Lundbeck requirements Required Education,… more
    HireLifeScience (04/22/24)
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