- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. Collaborates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... 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. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...relevant experience is required with a BSc requiredExperience in clinical operations methods and processes in industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...a pharmaceutical, biotechnology, or CRO required. Training & Development, Operations and/or Learning and Development experience preferred A minimum… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be a key ... to understand training needs and translate into actionable and enriching associate learning curricula and fostering connections among commercial associates. This… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing,… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a ... clinical studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative...and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …include ensuring compliance with international trade regulations and optimizing supply chain operations . The Associate Director , CSCL Customs & Trade ... S** **ummary** This position will play a crucial role in managing the import and export operations for Clinical Supply Chain Logistics (CSCL). Responsibilities… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Sciences - Ophthalmology - 2406190657W **Description** At Johnson & Johnson, we believe health is everything. Our strength in ... at https://www.jnj.com/. Johnson & Johnson is recruiting for an ** Associate Director , Clinical Project Scientist...clinical development plans, trial protocols, and supports the operations group with trial set up and monitoring and… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology...CPP leader can independently complete the day to day operations for the clinical pharmacology aspects of ... - 2406190600W **Description** Johnson & Johnson is recruiting for an ** Associate Director , Clinical Pharmacology and Pharmacometrics (CPP)** located in… more
- Bristol Myers Squibb (Trenton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Clinical Nurse Consultant** _The Clinical ... Director and VP of Hematology, the CNC Associate Director provides operational support for executing...align with key organizational stakeholders on role of the Clinical Nurse Consultant in achieving Hematology organizational priorities +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Imaging will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical trials ... charters and statistical analysis plan. + Work closely with Clinical Imaging Operations and imaging CROs to...study's imaging components and endpoints. + Serve as Study Director for clinical trials focused on qualification… more
