- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is responsible ... of critical quality risks and issues that may affect BMS. The Senior Director , Clinical Quality Audit strategy is also responsible for effectively… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development... results and provide a guidance to prepare high quality reports working with Medical Writing + Working with ... within the respiratory clinical development program at Teva! The Senior Director , Clinical Development is responsible for the development, execution and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and assuring effectiveness in delivery on quality objectives and a strong quality voice. Additionally, the Senior Director will collaborate closely with ... by advancing the care of patients with life-threatening diseases. ** Senior Director , GVP** **Audits** The Senior...for driving the integration and peak performance of R&D's Quality Management System, across Clinical Development and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical ... The Director Clinical Sciences, Hematology, leads in...and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional… more
- System One (Florham Park, NJ)
- …of 8 -10 years ( Director ) or, minimum 10-12 years ( Senior Director ) of experience in medical operations, clinical operations, or a related field within ... Job Title: Director / Senior Director , Medical Operational...clinical operations, regulatory affairs, commercial and marketing, and quality assurance, to drive alignment and achieve operational goals.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that supports global registration and commercialization ... help create possible, together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. ... is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …short- and long-term goals, lead the MR group to deliver timely and high- quality medical review, ensure the MR process and procedure in alignment with regulatory ... in Patient Safety cross-functional teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical review… more
- Bristol Myers Squibb (Madison, NJ)
- …automated, efficient organization dedicated to achieving industry-leading medical quality , compliance, and cost effectiveness. Builds Medical Review capabilities ... abilities. Medical Review: Provides guidance regarding medical review of individual clinical trial and post-marketing reports. Oversees single case processing vendor… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …statistical support to clinical studies or programs with the guidance of senior level statisticians (ie, Associate Director or higher) which includes, but is ... Senior Manager Clinical Statistician Date: Jan...for budget planning. + Manage and Deliver assignments with quality and within timelines. + Possible to have direct… more
- Bristol Myers Squibb (Summit, NJ)
- …project/products, to Health Authorities and RGO . + Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit ... Medicine + Oversee the Data generation and data integrity from laboratory work and non- clinical phase projects + Ensure Quality is Designed into non- clinical … more
- Bristol Myers Squibb (Summit, NJ)
- …collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. * As part ... lives. Read more: careers.bms.com/working-with-us . Position Summary The Associate Director , RBQM - HOCT, ICN will mainly be responsible...with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from… more
- Bristol Myers Squibb (Summit, NJ)
- …collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. + As part ... their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , RBQM - HOCT, ICN will mainly be responsible...with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from… more
- Bristol Myers Squibb (Summit, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director , Quality Governance will mainly be responsible for ... designing, developing, and implementing an effective Quality & Compliance Governance framework across nonclinical, clinical and pharmacovigilance functions that… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **POSITION SUMMARY:** The Executive Director , Cell Therapy Quality Analytical Science & Technology ... drug products, and finished labeled drug product. The Executive Director , Cell Therapy Quality , Analytical Science &...adaptable leader who supports the VP of Cell Therapy Quality , the senior Cell Therapy Leadership Team,… more
- Sunrise Senior Living (Fairfield, NJ)
- …members. Quality Assurance and Regulatory Compliance: * Track, trend and report clinical quality data to identify risk. * Actively participate as a member ... the community Quality Assurance and Performance Improvement committee. * Lead clinical quality and process improvement initiatives within the community to… more
- Bristol Myers Squibb (Summit, NJ)
- …writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to ... a ctivities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review .… more
- Sunrise Senior Living (Basking Ridge, NJ)
- …available for our customers at peak service delivery days and times. **ABOUT SUNRISE** Sunrise Senior Living has championed quality of life in senior care ... **_Sunrise Senior Living was again certified as a Great...ever worked, simply because of the people. We provide quality care in an environment that feels like home.… more
