- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director … more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... and maintain a risk-based and scientific-based quality system to support GCP .Oversee regulatory agency inspections and vendor audits.Ability to ensure that a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure ... ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and programs… more
- Merck & Co. (Buffalo, NY)
- Job DescriptionPosition Responsibilities The Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert ... including field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesPreferredField-based medical experienceResearch ExperienceDemonstrated record… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming, and ... automation, reporting, and data exchange solutionsEnsure all programming solutions comply with GCP , 21 CFR Part 11, and CDISC ODM StandardsData Quality &… more
- Eisai, Inc (Nutley, NJ)
- …the Quality management system. This role is responsible for Good Clinical Practice ( GCP ) and for assuring the compliance of projects, products and programs with ... Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance is from :236,900-310,900Under current guidelines, this… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... compliance with applicable domestic and international regulations and applicable ICH/ GCP guidelines to ensure patient safety for company's products.Provide oversight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... for projects/studies. This individual has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... clinical and safety databases, preferredFamiliarity with Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi Sankyo, Inc.… more
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