- 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials.- Global Clinical Supply is accountable for the planning, sourcing, labeling, packaging and delivery of … 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Genmab (NJ)
- …(including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other ... a key role in the effective implementation of the global development strategy leading or co-leading one or more...clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory… 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
- Merck & Co. (Rahway, NJ)
- …the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance ... Job DescriptionOur company is a global health care leader with a diversified portfolio...medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage… 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
- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight ... be our best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible for the oversight… 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
- 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
- Merck & Co. (North Wales, PA)
- …that the requirements for the portfolio of pipeline products are clearly articulated. The Associate Director will report directly to the US Marketing Leader for ... work across the enterprise with colleagues in US Payer Marketing, Global Commercial, Clinical Development, Data & Analytics and Outcomes Research to support the… 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
- 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
- Merck & Co. (North Wales, PA)
- …enrollment and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies ... Job DescriptionRole SummaryThe Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug ... - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Insmed Incorporated (Chicago, IL)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… 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
- Merck & Co. (Lower Gwynedd, PA)
- …Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… 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 ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
