- Merck & Co. (North Wales, PA)
- …Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible ... Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing… more
- Merck & Co. (North Wales, PA)
- …Portfolio Marmeting Team, Integrated Account Management , Learning and Development, Clinical Review Teams, Legal and Compliance. In addition, this individual will ... development, including a communication cascade plan in conjunction with Director of Commercial Operations (DCO)Contracting point(s).Collaborate with brand teams to… more
- Merck & Co. (North Wales, PA)
- …and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in ensuring ... with talented and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study teams,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are an equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal… more
- 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)
- …support of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage ... diseases and immune disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality ... and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and… 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, ... activities with functional groups within Daiichi Sankyo, Inc. related to assigned products/ project areas such as the clinical supplies organization, Reg… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and governing the medical affairs omnichannel engagement strategy. The Associate Director - MOE will work with one… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...and oversee completion of clinical trial protocols. Provides… 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 ... meet business goals, including change management and implementation planning, for GOCD non- project related initiatives. The Associate Director , GOCD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... TA including at all PMRT meetings and through ad hoc meetings with project owners. Partner with colleagues responsible for PGC medical review to ensure seamless… 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)
- …This position works independently in simpler studies/models and interacts with internal project teams. Responsibilities Analyzes and presents MS Analyses of Phase 1 ... MS study reports for Phase 1 to 3 studiesInteracts effectively on internal project teams as well as independently in simpler studies/modelsWorks with and influences… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… 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, ... project management, change management and risk management.Responsibilities ...statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or medical device setting required-… 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 ... SAS and R. The position will require proven skills in continuous improvement, project management, change management, and risk management. The position will act as… more
