- 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 ... in a global pharmaceutical organization. Relationships Reports to Vice President, Risk Insights & Management . Manages teams responsible for Policies &… more
- Genmab (Plainsboro, NJ)
- …BLA submissions, tracking of progress of PMRs and PMCs, etc. Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... hours per week. Responsibilities: This internship will support multiple projects in IT Risk & Security Governance. Partnering with team members, the intern will gain… more
- Genmab (Plainsboro, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development… 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
- Aequor (South San Francisco, CA)
- …ultimate goal of driving data -driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the ... of risk control strategies, and implementation of risk mitigation activities. Collaborate with the global ...teams to conduct data surveillance and issue management by defining consistent risk control strategies… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division , is accountable for managing the 'end-to-end' ... consultation or operations support needsEnsure an exquisite partnership with Global Clinical Trial Operations, Regulatory and other Development Sciences and… 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)
- …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 ... to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data warehouses and data lakes, to support efficient and effective data management and analysis. Build and maintain robust, scalable, and high-performance ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...of complex data projects and development of data management technologies. Provide technical expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global process harmonization ... centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... while being able to influence to gain alignment with stakeholders through use of data and logic.Support creation and management of all aspects of a given… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and ... Phase 3/4 program.This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this… more
- Merck & Co. (North Wales, PA)
- …addressing Medical information and review specialist Actively contact and interact with Risk Management Safety Team(s) when requiredAct as subject matter expert ... cross-functional teams, including the Promotional Review Team, and the US and Global Medical Affairs Teams. In Promotional Review Team, the Medical Consult and… more
- Merck & Co. (Rahway, NJ)
- …experience with ERP systems (eg, SAP), demand planning tools, and inventory management systems. - Familiarity with data analytics/visualization software . - ... Job DescriptionThe Global Clinical Supply organization is accountable for managing...connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and… 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
- 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 ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...dosage forms (liquid, lyo, drug-device combinations)Review and approval of data and technical documentsAbility to recruit, select, develop, and… 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, ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial participants… 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
