• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …centered around rare diseases and immune disorders.Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong...Reviews and provides input to SOPs, SOIs, and process guides. Clinical Study Start-Up Documentation : Reviews all … more
    HireLifeScience (03/19/24)
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  • Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines Build effective teams that apply… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group within the Chemical Engineering Research & Development ... job that provides a high degree of technical and management responsibility. -The Director - Automation Leader position will report to the Senior Director ,… more
    HireLifeScience (03/26/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (North Wales, PA)
    Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects ... review and final approval for all submissions and associated documentation . Provides expertise as worldwide regulatory representative to Product Development… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned ... and proactively represented at program level and along the clinical trial process in support of a proactive quality...KQIs at the respective GPTs and prepare respective management documentation for the QA Head for review at the… more
    HireLifeScience (02/24/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the product strategic analysis plan. In collaboration with the development team and/or clinical safety team, this position provides feedback on the clinical ... agencies. Collaborates with other groups at DSI in preparing documentation for regulatory agencies, reimbursement agencies, or other organizations. Maintains… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to internal and external manufacturing sites. Review technical documentation (protocols, reports) associated with manufacturing, technology transfer, site-to-site ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... Joint-GPT as applicable.Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.Keeps current with… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
    HireLifeScience (02/23/24)
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  • Merck & Co. (Rahway, NJ)
    …responsibility. The Senior Specialist - Process/Facility Engineering position will report to the Director , Engineering and will be a member of the EF Team at the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
    HireLifeScience (03/24/24)
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  • Merck & Co. (Rahway, NJ)
    …Development and Maintenance (EDM) Facility Specialist Engineering position will report to the Director , Engineering and will be a member of the EF Team at the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
    HireLifeScience (03/15/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …Plan, manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support ... & timely completion of all validation deliverables. Relationships Associate Director . Essential Functions Perform, review & approve validation/revalidation. Must be… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …memorandums Other Responsibilities: Assist with the creation and maintenance of process documentation for all responsibilities Support Tax Director and US Tax ... in US Federal, international, state, and local tax practice. Relationships Position reports to Director of Tax Operations at Novo Nordisk Inc. (NNI). As part of NNI… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (Rahway, NJ)
    …responsibility. The Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The… more
    HireLifeScience (03/19/24)
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  • Director - Clinical

    Stanford Health Care (Pleasanton, CA)
    …**A Brief Overview** Reporting the Executive Director , Mid-Revenue Cycle, the Director , Clinical Documentation Integrity is responsible for developing a ... unified, multidisciplinary, outcome-focused clinical documentation integrity program. This position evaluates...reporting of information is accurate and complete. The CDI Director will collaborate extensively and in a collegial manner… more
    Stanford Health Care (03/11/24)
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  • Clinical Documentation Manager

    AdventHealth (Maitland, FL)
    …The Clinical Documentation Manager will report directly to the Regional Clinical Documentation Director and will work extensively with CDI teams, ... (SOI) and risk of mortality (ROM) in cooperation with the Director of Clinical Documentation Improvement and all other operational hospital departments.… more
    AdventHealth (03/23/24)
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  • Clinical Documentation Integrity…

    AdventHealth (Orlando, FL)
    Documentation Integrity Physician Educator will report directly to the Regional Clinical Documentation Director and will work extensively with CDI ... creating a holistic environment. **The role you'll contribute:** The ** Clinical Documentation Integrity Physician Educator** is a...of the patient record, upon request of the CDI Director and Vice President of Clinical Services.… more
    AdventHealth (03/20/24)
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