- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: ... leader plays a critical part in designing and driving the core risk management operations of the E&C team, ensuring the identification, assessment, and… 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 . ... is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply… 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)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... of Works (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR Organization. Additional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external… more
- Genmab (Plainsboro, NJ)
- …of corresponding actions and processes.Knowledge/SkillsExcellent knowledge of security and risk management frameworks and standards (eg NIST, ISO).Excellent ... and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information… more
- Genmab (Plainsboro, NJ)
- …approving the CV of PL/PMRisk ManagementIdentify study risks with the CTT and oversee risk management activitiesMaintain and oversee the CTT issue log and ensure ... the CTM role too.ResponsibilitiesLead the Clinical Trial Team (CTT) and Trial Management (TM) teamDefine and align CTT goals collaboratively with the teamReview and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex ... immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic… more
- 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)
- …communication, planning and management of schedule, budget, scope, issue risk management , and quality/outcomes. Communication: Ensure that assigned PMs ... initiative is on track and adheres to the strategic goals. Issue and Risk management and reporting: Ensure that assigned PMs identify and manage issues and risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Support at Novo Nordisk is responsible for ensuring effective centralization and management of HR budgets, particularly for P&O initiatives. This role provides ... HR operations within the organization. By exercising financial prudence, identifying risk areas, and maintaining transparent reporting, the role supports the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Champions a proactive approach to ethics and compliance, focusing on partnership, risk mitigation, and prevention Informs management of ethics & compliance ... Ethics & Compliance (E&C) strategy by working with the Director , E&C Program Strategy & Operations in creating and...to executing E&C strategy and initiatives, and responding to risk Develops communications plans to disseminate information to E&C… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and ... and inspections to provide study and/or program-level information as needed.Project Management : Responsible for on-time completion of medical coding activities under… more
