- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions.This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, functional ... units and corporate functions.Lead Training function team and Document and record management function team to enhance training and document and record management … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sourcing projects and building inferences to develop sourcing strategies.Knowledge of Risk Management process and developing mitigation plans.Proficient in ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Director , Global Sourcing (Direct Materials) as part of the Technical Operations team… 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)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the… 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)
- … 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)
- …(MLDP) which recruits and accelerates future talent for the division. The Associate Director , Alliance Management is responsible for managing multiple aspects of ... enterprise manufacturing functions. This includes the Strategy and Portfolio Management office, Global Supply Business Development (GSBD) which evaluates… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Sustainability Strategy & Engagement will join the Company as a member of the Social Impact and Sustainability (SIS) function, ... sustainability, access to health, employee engagement, and ethics and values. The Associate Director will serve as a trusted advisor to business leaders , including… more
- Merck & Co. (Rahway, NJ)
- …, Multitasking, Outsourcing, People Leadership, Performance Monitoring, Process Automations, Risk Management , SAP Enterprise Resource Planning (ERP), Social ... our organizational needs-In addition to the long-term strategic roadmap, the Senior Director of CSS is accountable for day-to-day management and business… 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)
- …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)
- …The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
