- Merck & Co. (Rahway, NJ)
- …help drive technology optimization, align teams to overall Security and Compliance Strategy and drive technology and architecture blueprints re-use.The ideal ... Knowledge of IAM, Network Security, Endpoint Security, Security Operations, Risk and complianceStrong Grasp of Architectural Principles and Technologies: Deep… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...and external stakeholders of R&D Quality.Support the oversight and management of CAPAs by tracking and following up on… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... hierarchy both within and across organization.Candidate will join our Project Management Office (PMO) for one of our Company's Enterprise-wide Accelerate multiyear… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ensure all systems are operating well as ... designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial...delivery and follow through execution.- Assist with the daily management of the customer support ticketing system for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …-based monitoring (RBM) and Central Monitoring.Responsibilities:CRA Monitoring Oversight Management :Support monitoring oversight strategy to ensure quality and ... for monitoring the following CRA central oversight activities: Determine CROs compliance with monitoring plan for on-site and remote site visits (expectations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing ... Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a… 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 ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal advisor for the ... both independently and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third parties (vendors,… more
- Merck & Co. (Rahway, NJ)
- …satisfaction, driving continuous improvement in delivery efficiency and quality.Lifecycle Management and Compliance :Oversee the entire product development ... people are the key to our success, which is why our Global Supplier Management and Workplace Services team in Enterprise IT works to attract, develop, retain, and… more
- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs ... companyEducation:Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a… more
- Merck & Co. (Rahway, NJ)
- …of containment philosophies for potent compoundsExperience with Process Safety Management , Industrial Hygiene/Potent Compounds and Ergonomic Risk Assessment ... development through the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility and will… 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 ... well as advancing a culture of scientific excellence and compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... 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)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... Coordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... cross-functional understanding and to support project timelines.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... succession plan for key positions within the functional area (scientific and management pathways), including their own role.- The position is responsible for… more
- Merck & Co. (Rahway, NJ)
- …in small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) /Quality by Design (QbD) methodologies and tools ... projects, the incumbent is expected to help transition characterization work execution/ management to CCT ownership.The incumbent is expected to quickly develop and… more
- Merck & Co. (Rahway, NJ)
- …internal sites and in collaboration with external partners. Proactive resourcing planning, risk assessment strategies and budget management will be necessary. ... of transition to the clinic in accordance with preclinical workflows including management of API supply during this period.-Nature and Scope of PositionThe Director… more
