- Merck & Co. (Rahway, NJ)
- …efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with ... as collaborative, and innovative culture in GRACS for business process management and continuous improvement.-Establish and lead assigned domain Global Process… more
- Merck & Co. (Rahway, NJ)
- …with the AVP, Strategic Planning & External Engagement leadership team (LT) and Director , Strategic Operations Team to conduct regular, actionable analysis and ... Job DescriptionThe Executive Director , Policy Development and Strategy is a key...analysis of activities and progress -for GPP LT performance management and decision-making. Direct maintenance of platform, building and… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the Procurement lead for R&D Procurement Project and Change Management initiatives. This includes strategically leading, overseeing and prioritizing business ... achieve lasting benefits. Role will also own the road map, oversight and change management of the entire portfolio of special project. Position will also play a key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations, BDM and DLT members. He/she will also serve as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global ... Conference on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and...team members, and to a limited extent with senior management , and outside vendors; works independently for all phases… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as ... from CCDS; review and approve CCDS/labeling agreements for licensing partners. Conduct Label Review Committee Meetings: Independently or through oversight of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, provides input on ICF… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position are to create the model-based drug development plan, design, conduct , and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase ... interacts with regional and global project team members, senior management , and outside vendors.Responsibilities:Responsible for all aspects of Clinical Pharmacology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, Provides input on ICF… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as ... from CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners. Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Merck & Co. (Rahway, NJ)
- …a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.Corporate Audit and Assurance Services (MCAAS) ... includes a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in the global headquarters in Rahway,… more
- Merck & Co. (Rahway, NJ)
- …to audit to the relevant requirements.Under the direction of the Audit Director and the Auditor-in-Charge ("AIC"), the Specialist will:Participate in the execution ... to work as a team member on audits with management supervision.Under the direction of the AIC, partner with...of integrity and quality. Show good judgment in the conduct of work.Education Minimum Requirement:Bachelor's Degree in Computer Science,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders ... include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality, and… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.Job Summary The Director is responsible for developing strategies for assigned product(s) and execution of HEOR and ... research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more