- Early Warning Services, LLC (New York, NY)
- …for executive leadership and external audit and regulatory oversight agencies. Overview The Director , Risk Management is responsible for the development, ... risk leader aligned to a Data and/or Technology team. Provide day-to-day risk management guidance and oversight as part of the First Line of Defense risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... trials and submissions work.Proactively identifies and manages risks for the data management function and supports functional risk identification/ management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision… more
- Merck & Co. (Rahway, NJ)
- …Organizational Change Management , Organizational Changes, Personal Initiative, Project Management , Readiness Assessments, Risk Management , Risk ... Director , Business of IT Strategic Communication and Change Management role is a great career move for you!...Business of IT program and report to the Executive Director of IT Strategic Communications and Change Management… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of ... end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this ... years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (Rahway, NJ)
- …launch planning tool, ensuring adherence to timelines, budgets, and resource allocation. Risk Management : Identify potential risks and interdependencies across ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic… more
- Merck & Co. (Rahway, NJ)
- …Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization.… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- … Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality Management , Quality Oversight, Quality Risk Management , Quality Systems ... activities and develop strong working relationships with external quality management personnel. The incumbent would be the key quality representative… 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 ... including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and execution of global product and project… more
- Merck & Co. (Rahway, NJ)
- … Management , Healthcare Technology, Innovation, Internal Project Management , Management Process, Promotional Review, Risk Management , Scrum ... Job DescriptionGlobal Project and Alliance Management (GPAM) resides within the Research and Development (R&D) organization at our Company's Research & Development… more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... Associate Director :Leads a small team through financial and compliance audits...audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in… more
- Kenvue (Summit, NJ)
- Kenvue is currently recruiting for a: Sr Director Contract & Asset Management What we do At Kenvue , we realize the extraordinary power of everyday care. Built ... Location: Fully Onsite What you will do Kenvue is currently recruiting for: Senior Director T&D Contract & Asset Management This position reports into Brian… more
