- Formation Bio (New York, NY)
- … Affairs lead is responsible for developing and directing the regional regulatory strategy , objectives, policies, and programs pertaining to developing and ... for support of global registration and life cycle support and the leadership of regulatory strategy for projects that are currently US focused, but potentially… more
- Eisai, Inc (Nutley, NJ)
- …with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing ... that optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance… more
- Merck & Co. (Rahway, NJ)
- …to regulatory documentation.- - - Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business ... regulatory content Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform… more
- Merck & Co. (Rahway, NJ)
- …Analytical Technology (PAT), Process Scale Up, Regulatory Compliance , Scientific Innovation, Strategic Leadership, Strategy Implementation, Technology ... a senior scientific leader, the successful candidate will shape strategy , drive innovation, and ensure robust, scalable, and compliant microbial fermentation… more
- Merck & Co. (Rahway, NJ)
- …Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance , Regulatory Reporting, Scientific ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Merck & Co. (Rahway, NJ)
- …development strategy , study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... launches.Principal Responsibilities:Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging… more
- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Merck & Co. (Rahway, NJ)
- …for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.-The specific role will ... DCT deliverables including - robust processes & analytics, an integrated control strategy , successful tech transfer packages, filing and approval, and a robust… more
- Merck & Co. (Rahway, NJ)
- …to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations. ... and compliance programs to identify gaps against internal standards, regulatory expectations (eg, FDA, EMA), and industry best practices, generate action plans… more
- Merck & Co. (Rahway, NJ)
- …at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define ... group strategy and to lead a team of scientists in...- Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) and… more
- Merck & Co. (Rahway, NJ)
- …Division, Clinical Development and Digital Solutions (CDDS) value team, the Business Strategy Partnership (BSP) organization is seeking a highly motivated Senior ... the complex clinical development ecosystem. Reporting to the BIA team lead, the Senior Specialist / Information Architect will play a key role in aligning technology… more
- Merck & Co. (Rahway, NJ)
- …the business including discovery, development, manufacturing and supply, regulatory , business development, commercial groups, and other legal ... To:Working independently through product development teams to devise a patenting strategy with the goal of building robust portfolios of intellectual property… more
- SMBC (Jersey City, NJ)
- …**Qualifications and Skills** + 4-7 years on data analytics, data quality, and compliance of finance or financial regulatory reporting. + Exceptional written and ... focused on implementation of processes, methodologies, and systems that meet regulatory requirements and industry best practices. Within the larger Finance Change… more
- SMBC (Jersey City, NJ)
- …to its employees. **Role Description** To support SMBC Americas' business growth strategy , SMBC Finance is executing a major initiative to review and enhance ... Working with core Finance teams and other key colleagues (Technology, Risk, Compliance , etc.), Finance Change is primarily responsible for establishing and managing… more
- HSBC (New York, NY)
- Senior Sales Manager Brand: HSBC Area of Interest: Commercial Banking Location: New York, NY, US, 10001 Work style: Hybrid Worker Date: 15 Nov 2025 In compliance ... teams to identify and develop business opportunities, jointly formulate client engagement strategy to deepen HSBC's global cash management wallet share and grow… more
- Neuberger Berman (New York, NY)
- …and other control groups to support effective operational risk management and regulatory compliance . + Contribute to fostering a culture of client-centricity, ... Operations team will provide critical support in executing the operational strategy for Neuberger Berman's Alternatives platform. This Operations Project Manager… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, ... healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.Responsibilities- -Lead the… more
- Northwell Health Physician Partners (New York, NY)
- …and best practices to optimize clinical outcomes, enhance patient experience, and ensure compliance with all regulatory requirements. The VP of Quality will work ... Dr. John Q. Young, Chair and Senior Vice President of Behavioral Health and Dr....plan for quality in alignment with Northwell's overall quality strategy . The strategy will include oversight and… more
