- Merck & Co. (Rahway, NJ)
- …solutions.Experience with risk management tools and processes within the clinical quality framework. Skills :-Superior oral and written communication skills ... plans to implement ` quality by design` within clinical development programs, using a risk -based approach....of ` quality by design` principles in assigned clinical trials.-Develop Risk Assessment and Categorization Tools… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Merck & Co. (North Wales, PA)
- …and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… more
- Merck & Co. (Rahway, NJ)
- …Has a deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director ,… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... and data privacy standards. Your responsibilities span security operations, risk assessment, investigations, and compliance issue resolution for the Americas… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …proposals for formal presentation to senior management.Generates and maintains high quality risk management and communication plans. Independently identifies ... position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, Medical Affairs, Translational Research, ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …modalities and designing corresponding patient centric drug products through Phase 3 clinical development and line of sight to process validation and commercial ... talent development.Ensure adherence to all applicable regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements.Safety… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... but not necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support Good Pharmacovigilance… more
- Merck & Co. (North Wales, PA)
- …clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include: Collaborating cross-functionally in the ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
- Merck & Co. (Rahway, NJ)
- …with CRA Manager, CRM ( Clinical Research Manager, TA Head and CRD ( Clinical Research Director ) as needed.Works in partnership with GCTO (Global Clinical ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager, acts as...and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA… more
- Merck & Co. (Rahway, NJ)
- …with CRA-Manager, CRM ( Clinical Research Manager), TA Head and CRD ( Clinical Research Director ) as needed.-Works in partnership with GCTO (Global ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... and best practices as well as strong technical skills in working with ( clinical ) data. The position holder will require strong skills in continuous improvement,… more
- Tris Pharma (Monmouth Junction, NJ)
- … management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to ... safety information updates, potential risks mitigation, etc. Collaborates with appropriate clinical , medical, quality and regulatory counterparts and others… more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... automation activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while also facilitating tech… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… more
