- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team; Ensure the interpretation of statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved...promotional material to FDA as needed Generate ad hoc reporting requests Partner with PGC Coordinator on submission and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has experience working on Phase I-IV study ... and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills… more
- Merck & Co. (Rahway, NJ)
- … requirements.Preferred Experience and Skills:Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Ability and ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, Omnichannel Marketing and Media position reports to the Senior Director, Omnichannel ... Marketing (HCP and Patient). The associate director will also partner closely with key internal...and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong… 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 BDC ... automation systems.-Integration of control systems with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity… more
- Eisai, Inc (Nutley, NJ)
- …systems' roadmaps. Collaborate with global finance for the planning, approval and reporting of budgets and forecasts. Lead the definition of conceptual and logical ... with/using the following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... related to plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPs.Ability to work in a highly… more
- Eisai, Inc (Nutley, NJ)
- …of work experience in job offered or as Senior Systems Analyst/Data Analyst/ Associate Projects. Also requires 2 years of experience with/using the following (which ... gained concurrently): Working in Windows and UNIX environment; Data processing and reporting tools: Microsoft Project, MS Visio, Tableau, and Data Priviledge; System… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical aspects for ... protocol statistical section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.ResponsibilitiesAdditional… more
- SMBC (Jersey City, NJ)
- …diligent professional for the associate position within the Controllers - Regulatory Reporting Analysis Group. The primary responsibility and role will ... Dealer. + Assist in maintaining proper controls and documentation associated with regulatory reporting + Perform reconciliation of reported balances against the… more
- Insight Global (New York, NY)
- Job Description Insight Global is looking for a Trade Reporting Associate to join their global financial services client in NYC! This person would be responsible ... experience with global markets products and business activity in the expanding regulatory reporting space. We are a company committed to creating diverse and… more
- IFF (New York, NY)
- Associate Manager, Regulatory Affairs (Hybrid) Apply now " Date:May 13, 2024 Location: New York, NY, US, 07730 Company: IFF Family of Companies Job Description ... Associate Manager, Regulatory Affairs, NOAM (Hybrid) It's...managers, account teams and customers. This role will be reporting to the Director of Regulatory Affairs,… more
- SMBC (New York, NY)
- …futures, treasury futures & options, etc. CM is looking to hire a Policy Governance Associate or Vice President in their Regulatory and Control Group. The group ... is responsible for managing regulatory and internal audit matters, business processes, and policy...of meeting materials and arrangement of management briefings for reporting , approval or adoption) + Work with and supervise… more
- SMBC (New York, NY)
- …the documentation before submission to the regulators. + Coordinates responses to regulatory inquiries to contribute to effective reporting and communication. + ... Excel, etc.) to facilitate effective and efficient management status reporting . + Works closely with all regulatory ...status reporting . + Works closely with all regulatory and governance staff and assists with other GPDAD… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …a logical, systematic, sequential approach. Additional Information : + Location: Remote + Reporting to the Regulatory Manager, PCCTC Pay Range: $66,500 - ... Job Description Exciting opportunity at MSK: Join our team as aRegulatory Associate , Prostate Cancer Clinical Trial Consortium! We're looking for a dynamic clinical… more
