- Eisai, Inc (Nutley, NJ)
- …IT business stakeholders on business continuity, governance, and audits.Manage global IT Risk Management Procedure and third-party risk assessments.Establish ... teams in the execution of Risk and Compliance initiatives and support professional growth. Risk Management : Develop and manage global risk management … more
- Merck & Co. (Rahway, NJ)
- …customer requirements. --Principal ResponsibilitiesLead/contribute to device development, design controls and risk management strategy for the assigned ... Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy , Design Controls and Risk Management Our… more
- Merck & Co. (Rahway, NJ)
- … requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and development ... to the strategic direction of the company's product pipeline and regulatory strategy .Drive operational excellence initiatives that improve quality, compliance,… 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 ... impact assessments to ensure documentation is available for audits and inspections Management Strategy and Goals:Assist in developing PV goals, continued… 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 ... and mentor talentStrategic and critical thinking to advance biopharmaceutics strategy across the portfolioProject management skillsAttention to technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with ... years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and… more
- Merck & Co. (Rahway, NJ)
- …input on activities such as target product profile development, global regulatory filing strategy , launch readiness reviews, organized customer interactions, ... and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.This is an exciting opportunity to help patients and… more
- Merck & Co. (Rahway, NJ)
- …for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our ... dosage formulations.- The director should be well engaged with regulatory and industry trends to guide future activities for...role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical ... with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Position ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Serves ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more
- Eclaro (Chinatown, NY)
- …business, including trading and hedging strategies, supervisory procedures, P&L attribution, risk management , operational processes and regulatory landscape. ... skills Required Skills: Analytical Thinking Audit Planning Internal Audit Review Issue Management Risk Management Attention to Detail Automation Business… more
- JPMorgan Chase (New York, NY)
- …Risk areas. The Regulatory Engagement team is a centralized resource within Risk Management and Compliance that manages regulatory exams and ongoing ... Bring your expertise to JPMorgan Chase. As part of Risk Management and Compliance, you are at...will be responsible for the execution of the overall strategy for regulatory engagements. In this role,… more
- MUFG (New York, NY)
- … Risk Governance framework that aligns with MUFG's overall Information Risk Management strategy and regulatory requirements. + Risk Assessment and ... MUSI and MUBK to ensure unified approach to IT risk management , facilitating effective communication and coordination. + Regulatory Compliance: Ensure IT… more
- Citigroup (New York, NY)
- … matters. + Key stakeholder in senior forums covering strategy , risk management , governance, regulatory interactions, franchise reputation and/or highly ... legal advice to Citi's businesses and control functions, including the Independent Risk Management ("IRM") and Independent Compliance Risk Management… more
