- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with… more
- Genmab (Plainsboro, NJ)
- …collaboration, excellence, and a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, ... an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical Drug Supply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as a project manager/leader in planning and executing strategies for global drug development, commercialization and life cycle management. preferredProven ... Summary This position is responsible for providing project management, drug development expertise to Global Project Teams...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… 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)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... Director , Clinical Development Join a Legacy...diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… 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 ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex clinical and clinical pharmacology documents (eg, pivotal ... advise study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing… 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 ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data between partners in relation to marketed and clinical products.Strategic Partner Management:Oversees Local/ Global PV service providers responsible ... Event and drug coding conventions (MedDRA, WHO-DD)- Knowledge of FDA and global PV regulations, clinical and safety databases- Familiarity with Good … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document. May participate in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- 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...CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in… more
- Merck & Co. (Rahway, NJ)
- …a particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including ... monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical and translational… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... 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
- Merck & Co. (Rahway, NJ)
- Job Description Overview: The Director , Global Media Relations, is responsible for developing and executing a global media strategy that showcases our ... and collaborating with key our Company markets under the supervision of the Executive Director , Global Media Relations. The Director , Global Media… more
- Merck & Co. (Rahway, NJ)
- …degree (eg, MS, MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the different phases of ... drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Genmab (Plainsboro, NJ)
- …needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and other cross ... disease area expert in both internal and external venues including the US/ Global cross-functional teams, clinical development teams, advisory boards, steering… more
- Merck & Co. (Rahway, NJ)
- …team whose roles include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare.The primary objective of the Small Molecule Analytical Research and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... than) The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient … more
