- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as prepare potential audits linked to ... stakeholders to optimize Statistics technology, processes, and standards (improving quality/ inspection readiness, decreasing cycle times, and reducing costs). Qualifications:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections - May support the GCL, if applicable, in planning and executing the overall… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... to support Good Pharmacovigilance Practice (GVP).Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to patient's rights and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive and strategic way and through ... with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. Ensure proactive representation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... Ensure consistency of standard implementation across programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across multiple therapeutic areas and experience with regulatory submissions and inspections . Finally, this position has strong skills in continuous improvement, ... Analysis Plans, Clinical Study Reports).Actively participates in audits and inspections .Operational Efficiency / Continuous Improvement:Provides leadership within Data Management… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... safety data in pharmacovigilance and clinical trial databases Ensures audit and inspection readiness of Drug Safety team at all times; Ensures internal regulatory/PV… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... etc.Act as company's representative during regulatory agencies and customer inspections .Supports the investigation of product and related CAPAs. Partner with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on tech transfers and site activities. Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps at the manufacturing ... sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) perspective. Support technical recommendations for future manufacturing sites and their… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of ... Monitoring Controls, Optima Line and Ignition software implementation, AVI (Seidenader Inspection ), WLS Labeler, and Dividella Cartoner. Develop and maintain strong… more
- Dietz Property Group (Westerville, OH)
- …timely completion of service requests, performing preventative maintenance and unit inspections /rehabilitation as scheduled by the Community Director . JOB ... and unit rehabilitation as scheduled by the Maintenance Supervisor and/or Community Director . Complete required property and unit inspections and ensure any… more
- Merck & Co. (Rahway, NJ)
- …recruitment, retention, protocol deviations, regulatory documentation, site audits/ inspections and overall site performance.Identifies, assesses and resolves ... Manager, CRM (Clinical Research Manager, TA Head and CRD (Clinical Research Director ) as needed.Works in partnership with GCTO (Global Clinical Trial Operations)… more
- Merck & Co. (Rahway, NJ)
- …conduct,-recruitment, retention, protocol deviations, regulatory documentation, site-audits/ inspections and overall site performance.Identifies, assesses and ... CRM (Clinical Research Manager), TA Head and CRD (Clinical Research Director ) as needed.-Works in partnership with GCTO (Global Clinical Trial Operations)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure actions are taken (at the… more
- Merck & Co. (Durham, NC)
- …(QNs), and other key automation-related processesProviding direct support for regulatory inspections and audits and other validation activities by serving as the ... business area applications. Working Relationships Reports to the Associate Director Manufacturing Automation Frequent interaction with employees from other… more
- George Washington University (Washington, DC)
- …the Executive Director , Research Integrity and Compliance, leads external agency inspections and audits; provides support for audits and inspections to ... I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN Quality departments. ... but not limited to ISOtrain, Document Control, and/or Audits and Inspections , as necessary Physical Requirements 10-20% overnight travel required. Qualifications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and assessment status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and trending ... travel up to 10%. For team meetings, conferences, and to support inspections , as appropriate. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance with SDEA requirements. Relationships This position reports to the Director , Case Review & Compliance Reporting within Patient Safety. This position ... meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company (safety) SOPs Business partner liaison:… more
