- 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
- 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)
- 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)
- …product deletionsPrepares and monitors operating budget for programs, working with senior leaders, finance, legal/ compliance and other departments and divisions, ... Affairs as well as Outcomes Research. This position executes the patient engagement strategy in alignment with our company priorities. This leader is innovative and… 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)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as a Biologics Cell Culture Senior Scientist!Are you ready to take your career to the next level?We are seeking a strategic and ... be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …and communications stakeholders to refine, scope, and deliver technology solutions. Regulatory & Compliance Ensure technology solutions for communications comply ... a strong background in Product Management to shape the vision and strategy for technology solutions supporting corporate communications. The Product Manager will… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... listings)Demonstrated success in the assurance of deliverable quality and process compliance . Good working knowledge of reporting processes (SOPs) and software… 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)
- …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)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health.The Senior Associate will provide administrative support to senior leaders in the Biostatistics and Research… more
- Merck & Co. (Rahway, NJ)
- …with clear succession planning and capability development. Represent IT Finance on senior leadership forums; communicate strategy , risks, program status and ... executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS)… more
- Merck & Co. (Rahway, NJ)
- …Patient Engagement Lead will drive/execute the patient engagement and advocacy strategy in alignment with company priorities, work cross-functionally with various ... engagement activities through incorporation of the patient voice into internal strategy development and decision-making across our companySupports efforts to gather… more
- Merck & Co. (Rahway, NJ)
- …Project Management Information Systems (PMIS), Project Planning, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement {+ ... they need.- Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects. Sharing lessons learned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for the better. The Position The Associate Director, Consumer Social Media Strategy is a high-impact, hands-on leadership role responsible for the development, ... This role translates the corporate digital vision set by the Senior Director into best-in-class digital experiences, driving audience engagement, building brand… more
- Tris Pharma (Monmouth Junction, NJ)
- …negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory ... control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse… 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
- JPMorgan Chase (Jersey City, NJ)
- …success. Make a meaningful impact on our company, customers, and communities. As a Regulatory Strategy Senior Officer (Associate) in the Firmwide ... closely with senior leaders, develop expertise in regulatory strategy , and build relationships across multiple...You will play a vital role in ensuring effective regulatory interactions and compliance , contributing to the… more
