- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, ... development of clinical sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial participants for the assigned trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational...detailed Solution Architecture diagrams for ALL systems, integrations, and data flows. Work with the Enterprise Architecture team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing ... Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …prior to headquarters submission (ex-USA)Manages programs (patient support, educational or risk management ) to support appropriate and safe utilization of ... Job DescriptionRole Summary: The Global Senior Director Medical Affairs (Sr GDMA), Hematology is responsible for driving the development and execution of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and development opportunities for team members. Qualifications Bachelor's degree in Business, Risk Management , or Information Technology, Data Analytics, or ... role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing...CECO reporting to internal and external stakeholders Oversees the management and enhancement of the technology and data… more
- Merck & Co. (Rahway, NJ)
- …organizational transformation that reflects the evolving demands of our business. Risk Management :-Proactively identify potential technical, operational, and ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …across all geographiesExpand and/or further automate the use of data and new capabilities.Talent attraction, development, growth and retentionPerformance ... managementEnsure updated Business continuity plans and crisis management processes are ready at all timesOversight of our company's FTZAccountable for Trade and… more
- Merck & Co. (Rahway, NJ)
- …following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, and Good Documentation Practices (GDPs).-In addition to supporting ... internal resources and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a… more
- Merck & Co. (Rahway, NJ)
- …experience with ERP systems (eg, SAP), demand planning tools, and inventory management systems. - Familiarity with data analytics/visualization software . - ... & connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and ... to medical coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym list. Coordinate… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance objectives Works collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop healthcare compliance ... driving strategic risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The Business Partner is responsible… more
- Genmab (Plainsboro, NJ)
- …Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health ... This responsibility will involve collaboration with a partner. Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... in handling integration management , process and continuous improvement management , digital or data technology, operations, supply chain, manufacturing,… more
- Genmab (Plainsboro, NJ)
- …and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional communication, alignment ... stages.Strategic decision-making and the ability to balance speed, rigor, risk , and governance.Strong leadership in building resilient teams and fostering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
