- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to quality standards in ongoing projects and processes.Coordinate with the Quality Management System (RDPVMA) teams to support the audit functions, including ... initiatives that enhance the skills and capabilities of team members in quality management .Foster a culture of continuous learning and professional development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …groups within GCTO, especially with Clinical - Sciences and Study Management (CSSM) and regional Quality Managers, to deliver objectives. Collaborate with ... (GCD) regional office. Additionally, there are important interactions with, inter alia , Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... strategy for clinical supplies.-Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... our depot network and further through to distribution and management of materials to the clinical site.... Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related… more
- Eisai, Inc (Nutley, NJ)
- …vision and hands-on operational management strategies to expedite clinical operations activities.Ensure the timely, quality , and successful execution ... to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role... development programs across different phases.The VP of Global Clinical Operations is responsible for the management ,… more
- Genmab (NJ)
- …you and feel like a fit? Then we would love to have you join us!The RoleAs Senior Clinical Trial Associate (Sr CTA) you play a key role in supporting Clinical ... stakeholders, and overall trial coordination. This position is essential for maintaining high- quality clinical trial execution while ensuring adherence to Good … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management . Drives and leads the successful… more
- Merck & Co. (Rahway, NJ)
- …to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. ... (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply... Skills: strong knowledge of the principles of project management and clinical customer relationship management… more
- Genmab (NJ)
- …of our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities ... immunology experience preferredDemonstrated experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews...ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the ... to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management , Statistics). This position requires skills… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Genmab (NJ)
- …one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions ... adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for...developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as a compound… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... : This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Formation Bio (NC)
- …efforts to ingest and transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to deliver… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standards and in ensuring process compliance and deliverable quality .Significant expertise in SAS and clinical trial programming including data ... be programmed; an understanding of statistical terminology and concepts.Familiarity with clinical data management concepts; and ability to anticipate stakeholder… more
- Aequor (Devers, TX)
- Job Title: Environmental, Health and Safety Senior Specialist Location: Devens, MA ID: 62636-1 Duration: 12 Months Work Schedule: Please refer to the attached work ... functions across the Devens campus. This may include Commercial and/or Clinical drug substance manufacturing, support of Site Engineering (Maintenance and Metrology… more
