- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The ... SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectivesOversee and manage the maintenance and tracking of Quality Systems… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) standards . She/he also provides and monitors the ... meet production schedule and in accordance to strict SOP, FDA and cGMP standards Supports and assists with daily cleaning functions, as needed (vaults, floors,… more
- Merck & Co. (Rahway, NJ)
- …in critical early-phase program direction setting for the delivery device of drug candidates advancing through the pipeline. In addition, this position will ... participate as device and drug -device combination product SME in due diligence assessments of...knowledge of medical device development, regulatory requirements, and quality standards , with a knowledge of the requirements in successfully… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization ... applications (MAA), and new drug applications (NDA) Deliverables for meetings with Regulatory Agencies...medical writing practices and ideas and sets medical writing standards within the project area Routinely presents medical writing… more
- Merck & Co. (Rahway, NJ)
- …Development and Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... core teamsRemain current in relevant worldwide regulatory guidance and standards .Lead/support/oversee clinical supplies production with respect to device component… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... be part of the Quantitative Clinical Pharmacology (QCP) team and support drug development and commercialization activities. It is accountable for the Clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …market. The scope includes everything from raw material procurement to Drug Product release and patient shipment. Additionally, the role encompasses organizational ... requires strong leadership to guide the organization toward world-class standards through best-in-class manufacturing principles, processes, technologies, and talent… more
- Merck & Co. (Rahway, NJ)
- …programming activities for multiple and/or large/complex late stage drug /vaccine clinical development projects.- Accountability predominantly includes the ... process compliance, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and ... late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide… more
- Merck & Co. (Rahway, NJ)
- …:This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one ... and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practicesMaintain and manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical… more
- Merck & Co. (Rahway, NJ)
- …understanding of the interplay between formulation composition, process and stability of drug substance and drug product to ensure robustness, as well ... by developing and implementing biophysical and particle characterization tools for biotherapeutic drug products as well as mentoring other team members in delivering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... and Controls) activities of the portfolio small molecule and biological drug products consistent with the company goals; specifically, for the life-cycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.Maintain and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities related to calibration and instrumentationEnsures proper materials, tools, standards , parts and spare parts are identified and availablePerforms work ... generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (eg EPA, OSHA and DEA)Experience in a growth environment managing… more
