- Kennedys (Berkeley Heights, NJ)
- …their jurisdiction, including those relating to Information Security, Data Protection and Quality Management , refer any breach promptly to Risk & Compliance and ... is comprised of Billing, Collections, Financial Planning and Reporting, Management Accountants, Credit Control, Legal Accounting and Financial Operations Database… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … 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)
- …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)
- …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)
- … 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)
- … 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
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking an Associate Director , Program Management to drive the execution of critical drug ... seamless cross-functional coordination and execution.As a key member of the Program Management team, you will be responsible for translating strategy into execution… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Merck & Co. (Rahway, NJ)
- …to Schedule and Budget for Deliverables, Leadership of Teams, Vendor Management , And Demonstrated Communication With Senior LeadersAPI Small Molecule Manufacturing ... and Potent Compound Handling ExperienceProcess Safety Management , Emergency Management , And Incident InvestigationsFacilitating Process Hazard Analysis and… more
- buyer (New York, NY)
- …as a mentor and source of expertise to Project Managers and project staff. Risk Management :Identify and mitigate program risks, ensuring successful delivery of ... are looking for a driven, experienced, and hands-on Program Director to lead the implementation of HealthEdge, a comprehensive...program outcomes.Develop and implement risk management plans.Escalate judiciously to ensure project… more
