- 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)
- …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)
- …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
- 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
- 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
- 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
- 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
- Genmab (Plainsboro, NJ)
- …for new trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, ... essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in...a pivotal role in managing the relationships with the clinical vendors as well as coordinate and manage outsourcing… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …Procedures + Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and ... Director Clinical Development - Respiratory Date:...the cross-functional clinical development team + Supports Global Clinical Operations in clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Sciences, Hematology, leads in the...(TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical ... early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical Director (s) (MDs)… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the ... 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …internal expert in all aspects of regulatory medical writing, T&D, and clinical drug development + Knowledge of global regulations and guidelines for T&D and ... Sr Director , Global Regulatory Medical Writing &...extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.… more
