- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPut marketing strategy into action as you lead the development of our customer experience and campaign planning. Leveraging your strong ... insights, you'll shape and orchestrate fully integrated digital campaigns and confidently lead our agency and internal teams through the creative process for… 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation of the quality strategy in alignment with ... of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing… more
- Merck & Co. (Rahway, NJ)
- …including method development and validation, internally or externally, per design verification strategy . Lead strategy and execution of accelerated and real ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… more
- Merck & Co. (Rahway, NJ)
- …Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy , Regulatory Compliance , Risk Management, Stakeholder ... DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a...core member of the Value Chain Management Team, guiding strategy , ensuring compliance , and enabling manufacturing excellence… more
- Merck & Co. (Rahway, NJ)
- …Manager to join the RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will ... Technology Partners to own, set, and communicate the product vision, strategy , and outcome roadmap, aligned with strategic priorities.- Deeply understand user… more
- Merck & Co. (Rahway, NJ)
- …R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing system - a ... and automation/controls. You will set the product vision, align multi-year strategy with executive priorities, and partner closely with manufacturing leadership,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development ... across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a...to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance… 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)
- …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)
- …leader to shape and drive innovation across the Biologics pipeline, strategy , and science.Anticipate and solve scientific and technical challenges across projects ... and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for biologics in various stages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …per TA. Partners compliantly with respective home office functions, including Commercial Strategy and Marketing, Insights & Analytics, privacy, compliance and ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …and product usability. The Senior Director will champion enterprise-wide HF strategy , foster cross-functional collaboration, and represent the company externally to ... influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence Serve as a trusted advisor and coach to the HF… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contract lobbyists and customers, as necessary. Internal relationships include Legal, Compliance , Managed Markets Sales & Strategy , BioPharm, Medical, ... ready to realize your potential? The Position The Regional Lead of State Government Affairs sits within the State...state government affairs goals that advance Novo Nordisk's enterprise strategy as it relates to state legislation and policy.… 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
- 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
- Lundbeck (Staten Island, NY)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of ... of the activities described below Drive Formulary Placement For NNI Products Independent lead within NNI to develop RFP response for the targeted customers, manages… more
