- Merck & Co. (Rahway, NJ)
- …development, and Commercialization activities and develop strong working relationships with external quality management personnel. The incumbent would be the key ... Management , Project Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality Management , Quality Oversight, Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are ... Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data ...This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... RBQM activities and deliverables in terms of timeline and quality .- People Management Leadership: Accountable for the management , development, recruitment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mitigation strategies and process improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review Board) across the global ... around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in... management in close collaboration with the organization's quality management system, to assure robust knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Merck & Co. (Rahway, NJ)
- … Assurance (QA), Quality Assurance Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management , Quality Management ... Job DescriptionThe Quality Assurance Director will provide compliance...and resolve trends. Report results to Divisional and Regional Quality / Management councilsProvide guidance and consultation services for… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Merck & Co. (Rahway, NJ)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... acceptability and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The USMA Health Systems (HS) Director , Strategic Medical Implementation Lead, plays a critical leadership role in advancing the strategic ... across the Health Systems field medical enterprise.The USMA HS Director , Strategic Medical Implementation Lead, holds primary responsibility for integrating… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The Executive Director , Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global ... is a critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes...direction to teams leading the development and execution of high- quality evidence strategies and plans for products in ophthalmology… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of a HEDS Executive Director , the Senior Principal Scientist, Health Economics leads a team of health economists and outcomes ... economists and outcomes researchers.Accountable for team prioritization and development of high- quality health economic models and tools to support market access,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Associate Director , Global Scientific & Value Content-Healthcare Professional (AD, GSVC-HCP), position resides in the Value & ... Leadership Responsibilities:Leads projects and solves complex problems: Oversees project management , providing solutions to complex issues, and guides junior staff… more
- Merck & Co. (Rahway, NJ)
- …formulation and process development through process tech transfer, scale-up activities, quality investigations, change management , and authoring GMP standard ... product aseptic processing, equipment, and sterile technique.Experience in leading quality investigations and change management .Familiarity with United States… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, Quality Management , Regulatory Applications, Stakeholder Relationship ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Position provides field coaching, mentorship and management to the field-based Medical Liaisons, and develops and implements strategies:… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Merck & Co. (Rahway, NJ)
- …and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also ... Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management ,… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
