- Genmab (Plainsboro, NJ)
- …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 single or multiple clinical trials from strategy outline through to CSR by...outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical … more
- Genmab (Plainsboro, NJ)
- …authentic 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 Regulatory Affairs organization.In this role, you will work...Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... About the Department Our East Coast Global Development Hub brings together the best minds...NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and ... Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be...global regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, facilitate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new medicines to help people.Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... internal project team(s) and team leader(s) or US based Global Function leaders as a Finance Business Partner.Provides guidance...and is accountable for the development and control of Clinical Project Budget in support of Phase I-III … 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 ... The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead...These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within the 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 ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… 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 ... impact analysis, supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned compound(s) and therapeutic areas (TA), under the guidance of the Associate Director , GOMA Scientific Engagement.Contribute to the management and ... healthcare community to enable flow of information from/to medical community. Assists Associate Director , GOMA SE in developing Scientific Engagement strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …to the best of my knowledge. **Job Description** **Objectives:** As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the ... innovative therapies across the oncology portfolio through: + Analysis of unmet clinical need and potential therapeutic preferences + Development of Clinical … more
- Merck (Trenton, NJ)
- …and Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Director , Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization and… more
- Bristol Myers Squibb (Princeton, NJ)
- …to the Senior Director , Executive and Strategic Communications, the Associate Director , Global Technical Services Communications, is responsible ... executing strategic communication initiatives that support Bristol Myers Squibb's Global Technical Services operations. This role involves crafting high-quality… more
