- Merck & Co. (Rahway, NJ)
- …organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Genmab (NJ)
- …of protocol deviations across studies.Provide strategic guidance on data workflows and compliance across the clinical portfolio.Data Quality and ... Quality Management, is a strategic leadership role within Clinical Data Management. This individual is accountable for driving...regulatory compliance .Act as a Data Standards or Clinical Systems Lead as needed.Regulatory and Submission… more
- Eisai, Inc (Nutley, NJ)
- …the execution of all aspects of end-to-end clinical trials with the utmost compliance and quality consistent with Good Clinical Practice (GCP). This ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical...Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical ... your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of ...reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred. Basic QualificationsMust have 10 or more years of professional experience in Quality , IT compliance and clinical development in the pharmaceutical ... R&D & PV QA) ensures high standards of data quality and compliance within Global R&D &...organization.Champion and disseminate educational materials and initiatives related to quality concepts across global teams. Lead and inspire… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CDP planning and individual protocols to facilitate successful implementation of programs. Clinical Operations:Ensure high quality delivery of all studies for ... budget, so both can be managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the… more
- Genmab (NJ)
- …across programs and systems. This role reports to the Director, Team Lead of Clinical Programming.Responsibilities/tasks - including but not limited ... (SDTM) standards that support the scientific need of a study/program while ensuring quality , consistency and compliance to CDISC standards and other industry… more
- Novo Nordisk Inc. (Boulder, CO)
- …Development, Analytical Manufacturing, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead , API Manufacturing ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role....and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision risk, drive action plan development and ultimately improve commercial and clinical planning Design, execute and lead all capability benchmarking ... methodologies to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data… more
- Eisai, Inc (Raleigh, NC)
- …will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other EDCS ... and hhceco initiatives, the Director will oversee Global Logistics and Import/Export compliance for commercial, clinical , and research materials. This includes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to optimize laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical ... This position develops and proposes strategies for laboratory data ensuring all clinical trials meets quality requirements and best practices. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolutionProactively ensure that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy in close ... professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product...product profile to ensure appropriate management review of all quality and compliance related topics including the… more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also responsible to… more
- Merck & Co. (Boston, MA)
- …and clinical studies are designed and monitored optimally. Ensures that clinical documents are of highest quality .Interfaces with functional leaders within ... lead multi-tumor asset teams (asset team leads). Any clinical development staff reporting to the ATL will be...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Durham, NC)
- …product(s).- As a result, VCM Product Managers have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity ... work experienceBreadth of experience in large molecule (biologics/ vaccines) operations, technology, quality , and/ or supply chainDemonstrated ability to lead a… more
- Eisai, Inc (Exton, PA)
- …systems.Reviews and approves documentation of SOPS, SDLC tasks, and other GxP Systems Quality Assurance processes for use in supporting compliance with GxP ... a repository of controlled documents related to GxP Systems Quality Assurance.Internal and External Auditing and Compliance ...environments.2+ years in a leadership role in GxP Systems Quality Assurance. Must be able to lead … more
- Merck & Co. (North Wales, PA)
- …Data Management ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, ... for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are...enable f uture proofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 ( ie IDMP… more
