- 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 the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office ... to ensure risk management activities allow for effective preparation for inspections/audits. Serve a key support during Risk Management Inspections.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Clinical Development (GOCD) Functional ... management and implementation planning, for GOCD non-project related initiatives. The Associate Director , GOCD Functional Excellence must have excellent verbal… 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 stakeholders.Provides support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and best practices as well as strong technical skills in working with ( clinical ) data. The position holder will require strong skills in continuous improvement, ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… 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 ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... automation activities throughout the facility.-Primary Responsibilities:Provide process support for clinical manufacturing and R&D processes while also facilitating tech… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …time and within budget. The position may also collaborate with CROs ( Clinical Research Organizations) and manage oversight. The position will partner with internal ... - Responsible, with limited supervision, for study activities assigned, eg for a clinical study: provide input on the development of study protocol (design, sample… 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 ... and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, ... and procedures and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical … 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 ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
