- Merck & Co. (Rahway, NJ)
- …regulatory content Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Merck & Co. (Rahway, NJ)
- …the US improve patient experience, treatment adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The ... with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs)...Director will collaborate closely with the US patient support strategy (PSP) lead where relevant, with an… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team,...and post-market evaluation.Develop and execute the device risk management strategy , including the creation of device risk management plans… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... Responsibilities: Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from… more
- 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 ... marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global...registration and life cycle support and the leadership of regulatory strategy for projects that are currently… more
- Merck & Co. (Rahway, NJ)
- …regulatory , company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk ... to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.… 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)
- …experience-driven omnichannel engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and customer experience for ... may include, but are not limited to: -- Strategic Planning Communications: Lead the development and implementation of digital marketing plans to achieve business… more
- Merck & Co. (Rahway, NJ)
- …based on the business value and technical complexity of the IT solutions.ResponsibilitiesProduct Strategy & Roadmap Lead the applications under the Product and ... Management background to help us shape the vision and strategy of our software products in the clinical domain.The...solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a… more
- Merck & Co. (Rahway, NJ)
- …Analytical Technology (PAT), Process Scale Up, Regulatory Compliance , Scientific Innovation, Strategic Leadership, Strategy Implementation, Technology ... enzymes.As a senior scientific leader, the successful candidate will shape strategy , drive innovation, and ensure robust, scalable, and compliant microbial… more
- Merck & Co. (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... biomarker platforms.Development and execution of the early clinical development strategy for novel therapy/Immunology programs from Preclinical Candidate approval… more
- Merck & Co. (Rahway, NJ)
- …scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical ... of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development and Digital Solutions (CDDS) value team, the Business Strategy Partnership (BSP) organization is seeking a highly motivated Senior Specialist ... accessibility across the complex clinical development ecosystem. Reporting to the BIA team lead , the Senior Specialist / Information Architect will play a key role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Director, Key Opinion Leader Strategy & Engagement will lead a team and critically shape KOL strategy ... and launch KOL- and association-related brand/therapy area strategic objectives KOL Experience Strategy : Lead the execution of KOL experience strategies and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Strategy and Study Execution while exhibiting leadership qualities.Responsibilities- - Lead the core study team while project managing and collaborating with ... areas centered around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team… more
- Formation Bio (New York, NY)
- …clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving ... clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or ... audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Rare Disease), as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy , Legal, and ... Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes… more
