- Merck & Co. (North Wales, PA)
- …Functions & Responsibility Essential function(s) includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) ... Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg, safety and efficacy analysis datasets, tables, listings,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... collaborate to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming… 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
- Novo Nordisk Inc. (Phoenix, AZ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- 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
- 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …patient support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive impactful change ... degree or equivalent experience required Expertise in data analysis and reporting required Experience in ML/AI preferred Experience in Salesforce Healthcloud… 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
- 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. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication.-Specifically, the Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… 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
