- Merck & Co. (Rahway, NJ)
- …functional areas.Drive accountability for processes execution throughout GRACS through change management .-Develop, implement and report process objectives and ... process management organization capabilities (eg, lean six sigma, change management , executive-level facilitation, project management , negotiations,… more
- Merck & Co. (Rahway, NJ)
- …medical devices or combination productsExperience in design controls, ISO 13485, deviation management , change control, risk management /ISO 14971-2019 and the ... in biotech organizationsFive plus years in design control, risk analysis and change control management for medical device or combination productsDemonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- Merck & Co. (Rahway, NJ)
- …drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA, ICH, ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and ... regulatory CMC representative to project teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance, Pharmaceutical … more
- Merck & Co. (Rahway, NJ)
- …drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated ability to identify, mitigate ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... 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)
- …functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...Safety and Pharmacovigilance, Regulatory /Risk Management , Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship...functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital transformation unit,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... the IT functions. This role involves developing the HCP Engagements technology roadmap, leading innovation, communication strategies, identifying and managing KPI's,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... organizational units or project teams. This position has advanced skills in technology systems, content creation, word processing software and data management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development.Responsibilities:Designs and leads clinical trial sample… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... decisions including approach for tech development, manufacturing network strategy, and change control strategy/planning as chair of PAC-MT, etc.Manage (or have… more
- Merck & Co. (Rahway, NJ)
- …the activities of lab staff, including scheduling, training, and performance management .Ensure adherence to safety protocols and regulatory requirements within ... GMP product testingExperience in leading and supporting quality investigations and change managementExperience with internal / external audit process and authoring… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …Services portfolio also includes Fidelity Labs, the Fidelity Center for Applied Technology , F-Prime Capital, and Impresa Management LLC. At Fidelity, our ... a culture of ethical conduct and commitment to compliance, regulatory and legal obligations. In this role on the...days, every four weeks. These requirements are subject to change . Fidelity Internal Information Reminder: Per the Dynamic Working… more
- VNS Health (Manhattan, NY)
- …culture of strategic thinking and growth, encourage the team to embrace change , adapt to evolving healthcare landscapes, and consistently pursue excellence in ... manner.Engages in and contributes to the interdisciplinary team's utilization management activities and recommended interventions for members/participants. Establish procedures… more
- SMBC (Jersey City, NJ)
- …and monitoring and evaluating work. This position works closely with Director of Regulatory Reporting Change Management Department to ensure proper review ... employees. **Overview** The firm is going through a multi-year Regulatory Reporting Transformation program and this position reports into...program and this position reports into the Director of Change Management Department. You will work with… more
- SMBC (Jersey City, NJ)
- …benefits to its employees. **Background** This position reports into the Vice-President of Change Management Department and will work with other teams within the ... Data and Technology Departments to carry out the regulatory ...finance, or a related field + Experience in Banking, Regulatory Reporting and Risk Management projects +… more
- JPMorgan Chase (Jersey City, NJ)
- …landscape. **Job responsibilities** + Ensure effective identification, quantification, communication, and management of technology risk, focusing on root cause ... and skills** + 5+ years of experience or equivalent expertise in technology risk management , information security, or related field, emphasizing risk… more
