- Genmab (NJ)
- …perform sponsor oversight of relevant programming activities on the Biometrics vendor , ensure the quality and consistency of data standards to support the ... the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of… more
- Eisai, Inc (Nutley, NJ)
- …of the quality management system.Direct and oversee operational and budget management , vendor management , development & tracking of timelines, and ... Quality Assurance (CQA) strategy including audit and inspection management , issue management and oversight ...management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …escalates issues encountered at the department level.- Provides the highest level of CRO/ vendor oversight to ensure project plans are executed properly (eg, ... as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …effective CAPAs are defined, implemented, and tracked for closure.Oversee quality management within Medical Affairs teams for third-party/ vendor activities, ... QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for… more
- Insmed Incorporated (NJ)
- … oversight of CDMOs, CROs, and testing labs, including audit and vendor management experience.Proven expertise in root cause analysis, investigations, change ... change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive… more
- Takeda Pharmaceutical (Boston, MA)
- …Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) ... a new TLP, CCDS, USPI and EU SmPC.How you will contribute: Management of Labeling Cross-Functional TeamsLeads Labeling cross-functional teams providing leadership to… more
- Insmed Incorporated (NJ)
- …EMA, and ICH regulatory requirements. This role will support implementation and ongoing management of digital systems used in clinical trial operations, quality ... Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality Management Systems ProcessesWho You… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Call Center, Product Quality/Technical Complaints, Patient Safety Organization Call Center Vendor . Provides support and escalation channels for both internal teams… more
- Eisai, Inc (Nutley, NJ)
- …the disease state community. Direct and manage financial planning/forecasting and budget management , vendor management , timeline development & tracking, and ... of overall medical operating plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical… more
- Insmed Incorporated (San Diego, CA)
- …teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management , and external ... outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory Affairs, lead the development and implementation of… more
- Insmed Incorporated (NJ)
- …The individual will conduct packaging development projects from initiation through clinical and commercial manufacture (launch & beyond). Projects will consist of ... hands-on evaluation of packaging for conformance to project and regulatory requirements. Oversight responsibilities for commercial packaging sites and CMO'sTravel to … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards.Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines ... compliant facility operations according to cGMP requirements. This individual will provide oversight for a team of maintenance specialists and partner with cross… more
- Astellas Pharma (Northbrook, IL)
- … landscape and Astellas future strategic direction. Responsible to ensure compliance with vendor management and oversight processes and procedures and ... utilized by the Functional Unit. This position may include oversight of the relationship with vendors within the Functional...supporting clinical trials + Prior experience with vendor management relationships **Salary Range** $150K -… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- … Management :** Leads and develops systems for Clinical vendor management and vendor oversight . + ** Management Review:** Establish and ... Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. + **Audit Management :** Oversee the… more
- Sanofi Group (Morristown, NJ)
- …critical in helping our teams accelerate progress. Join our Vendor Performance Management Team as a **E- Clinical Outcome Assessment Vendor Category ... **Job Title:** eCOA Clinical Operations Vendor Category Lead- **Location**...Procurement and other relevant departments. COVCL functionally reports to Vendor Performance Management Head. We are an… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management + 8 years of relevant experience with a ... quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management + Experience working across a broad spectrum… more
- HCA Healthcare (Nashville, TN)
- …**Introduction** Do you want to join an organization that invests in you as a Vendor Resource Management Profee Coding Manager? At Parallon, you come first. HCA ... make a difference. We are looking for a dedicated Vendor Resource Management Profee Coding Manager like...will do in this role:** + Provides direct managerial oversight to vendors and Team Leads in management… more
- Huron Consulting Group (Van Buren, AR)
- …sustainable growth, optimize internal processes and deliver better consumer outcomes. The Vendor Management Manager provides management of standardized ... vendor cost and supporting Request for Proposal (RFP) processes. The Vendor Management Manager leads implementation and sustainability of standard vendor… more
- AbbVie (North Chicago, IL)
- …and accurate delivery of high quality, relevant, and timely adverse event management by providing effective oversight of external providers of Pharmacovigilance ... services for AbbVie. + Conduct oversight of vendors to ensure collection, assessment, and processing...ensure collection, assessment, and processing of adverse event information ( clinical and post marketing) is performed in a compliant… more
- Bristol Myers Squibb (Madison, NJ)
- …inspections and audits + Provides coaching and quality oversight of junior Data Management Leads **FSP/CRO/ Vendor Oversight ** + May act as core member of ... personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** Clinical Data Management key focus is to...the study team and provides FSP/CRO/ Vendor oversight for end-to-end Data … more
