- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be ... this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a robust risk management process with appropriate tools, serving as the expert in risk management for product safety teams.Prioritize areas for ... physicians and scientists across various regions, offering guidance and support to each product safety team in critical areas such as individual case medical review,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis role serves as an analytical expert to the US Health Economics & Outcomes Research and Real-World Evidence ... extraction of data gaps, collecting additional evidence from literature to support product value, and being an active participant in Integrated Evidence Planning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to help identify true root cause of investigations and assess product quality impact.Work closely with cross-functional teams to improve/streamline investigations ... compliance and technical feasibility of proposed changes.Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory… more
- Merck & Co. (Rahway, NJ)
- …of product development to be recognized as a project management/ product development expert within-the broader organization-- Proven ability to evaluate, ... across projectsParticipation in continuous improvement projects that require extensive product development experience and comprehension of our company procedures and… more
- Merck & Co. (Rahway, NJ)
- …strong candidate for the position of Senior Principal Scientist within the Biologics product development group. Primary duties: Be a seasoned biologics product ... will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Merck & Co. (Rahway, NJ)
- …and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee program strategy and execution, will ... or new clinical trials for investigational or marketed medicinesLeading cross-functional product development teams that oversee overall strategy and execution for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …objectives for inline, launch and emerging brands as well as alternative product access channels Manage the operations of digital NovoCare® patient access and ... and recommendations for management endorsement Function as subject matter expert on digital patient access support services while collaborating cross-functionally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …closely campaign development, competitive defense, and strategic evolution of the product Omnichannel Experience Strategy o Provide consumer insights to omnichannel ... customer experience is required Proven success in developing strategy through expert understanding of market and industry Ability to manage complexity, including… more
- Merck & Co. (Rahway, NJ)
- …your expertise in agile methodology to drive project successOperate as an expert in information technology product and project management-Advance your career ... your career in a dynamic and supportive teamInformation Technology Product /Project Management ExperienceDrive innovation and results as an Information Technology… more
- Merck & Co. (Rahway, NJ)
- …program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... human health), and balancing needs of patients & ensuring stable supply of product . Primary activities include, but are not limited to:--Interacts closely with key… more
- Merck & Co. (Rahway, NJ)
- …simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and ... and provide regulatory oversight for assigned products in order to optimize product labeling and obtain shortest time to approval by regulatory agencies.You will… more
- Merck & Co. (Rahway, NJ)
- …and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative ... sites and External Partners. Collaborate with internal teams to ensure seamless product supply with an end-to-end mindset. Initiate and drive change controls to… more
- Merck & Co. (Rahway, NJ)
- …well as through the interaction of Asset Teams and Disease Specific Product Development Teams (PDT) to evaluate potential indications in specific disease areas.This ... late-stage development plans; will work across TA areas to gain insights / expert advice regarding tumor specific development; will design and conduct basket studies… more
- Merck & Co. (Rahway, NJ)
- …we leverage technology to enable new organizational capabilities. We are seeking a Product Analyst to be a change agent for our order-to-cash process. This role ... small projects as a lead analyst, project manager, or as the subject matter expert . Account and manage for the demands per region and specific area and discuss… more
- Merck & Co. (Rahway, NJ)
- …clinical site. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... health), and balancing needs of patients & ensuring stable supply of product . -Primary activities include, but are not limited to:--Participates on the Clinical… more
- Merck & Co. (Rahway, NJ)
- …transfer, long term storage stability, qualification and licensure. Ensure that process/ product are developed and documented according to standard company practices. ... required to ensure viral safety and characterization of cell banks, and expert knowledge of cGMP principles and regulations.-Adaptability and agility to prioritize… more
- Daiichi Sankyo, Inc. (New York, NY)
- …Sankyo brands, and competitor products.Completes all assigned training.Serves as a disease state expert and provides a high level of product expertise and ... Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product , and its approved indications, providing approved disease state and … more
- Merck & Co. (New York, NY)
- …Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) oncology expert who engages in bidirectional exchange of scientific or medical information with ... Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non- product areas of interest to the company and replies to scientific… more
