- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs ... culture in Global Regulatory Affairs and Clinical Safety for business process management and continuous improvement.-Establish and lead assigned domain Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Informatics Services, Project Management and Operational Management . The Tech Lead must have the...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… 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)
- …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
- 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 ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team 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 ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...and post-inspection-related activities under the supervision of the IMT Lead . Management Review: Collect the data and information… more
- Merck & Co. (Rahway, NJ)
- …satisfaction, driving continuous improvement in delivery efficiency and quality.Lifecycle Management and Compliance :Oversee the entire product development ... lifecycleLeadership and management skills, with proven abilities to set direction, lead and motivate team members and the proven ability to drive organizational… 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)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... & connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs… 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
- 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 ... Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics… more
- Merck & Co. (Rahway, NJ)
- …organizational transformation that reflects the evolving demands of our business. Risk Management :-Proactively identify potential technical, operational, and ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization and join the leadership team of Small Molecule… 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 ... In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include...for key positions within the functional area (scientific and management pathways), including their own role.- The position is… 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)
- …in small molecule process characterization work by learning and utilizing Quality Risk Management (QRM) /Quality by Design (QbD) methodologies and tools ... leverages significant depth and breadth of scientific/technical experience to: (i) lead and contribute to assigned late-stage Active Pharmaceutical Ingredient (API)… 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)
- …and global functions such as infrastructure, engineering, system security, risk management , etc.Education Requirement:-Bachelor's degree in automation, ... analyzing and solving incidents, problems, identifying root causes and performing crisis management roles. Lead efforts to map and design operational service… 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)
- …communication and collaboration skills.Good organizational, interpersonal, writing, and time management skills. Lead and operate within a cross-functional process ... leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe,… more
