- 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
- 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
- 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)
- …rigorous technical support processes to support manufacturing sites, proactive risk management , performance monitoring, continuous improvement activities that ... and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection process in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope of work in collaboration ... with Outsourcing Procurement Management . Lead trial feasibility and site identification activities...and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead … 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)
- …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
- 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)
- …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)
- …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)
- …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
- 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
- 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
- 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 ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations and be responsible for the ongoing site ramp-up, daily operational management , as well as continuous improvement of cGMP Warehouse Operations within a ... team responsible for all inbound, outbound, material receipt & inventory management , and distribution processes for raw materials and final drug products.Establish… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the ability to positively influence peers, key stakeholders and management .Generates shift schedules, to ensure efficient coverage for all operational ... corrective and preventive actions, as necessary.Supports internal/external audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the… more
- JPMorgan Chase (Jersey City, NJ)
- …outside the box, challenging the status quo and striving to be best-in class. As a Compliance Risk Management Lead - Vice President in the Global ... Bring your expertise to JPMorgan Chase. As part of Risk Management and Compliance , you...control issues within the LOB; + Serve as GFCC lead in select Senior Business management forums;… more
