- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of ... areas centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and ... portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs activities. Represent Medical Affairs in new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase ... I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets...Budget Planning - Manages and is accountable for the development and control of functional budget in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex ... areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs. Facilitate ... areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and… more
- Merck & Co. (Rahway, NJ)
- …Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Senior/Executive Director /AVP in ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and ... external development project meetings. Conduct completeness, scientific accuracy, and ease...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... the development and maintenance of the CCDS, US and EU...PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development , Clinical Scientists, Clinical ... of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Clinical Director will manage the entire ... and joint internal/external research project teams relevant to the development of new compoundsThe Clinical Director...relevant to the development of new compoundsThe Clinical Director may:Supervise the activities of … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of ... Process Research & Development , Analytical Research & Development , and Pharmaceutical Sciences & Clinical Supply....Research & Development , and Pharmaceutical Sciences & Clinical Supply. The ideal candidate should have strong project… more
