- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourced or contracted activities utilizing both performance and quality measurements.The Associate Director, SCBM Financial Reporting & Strategy position ... management and liaises with internal/external stakeholders on cross-functional initiatives.The Associate Director, SCBM Financial Reporting & Strategy's… 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
- 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
- Merck & Co. (Rahway, NJ)
- …of, with input from internal stakeholders and knowledge of current regulatory requirements, the article selection, adverse event reporting , editorial, ... requirements.Maintains awareness of developments in the fields of medical information, regulatory policy, adverse event reporting , information storage and… 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (ie, collaborates with statisticians to ... scientific colleagues, the incumbent contributes to the design, data collection and reporting of clinical studies in a manner consistent with industry standards,… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Description: Global Clinical Data Standards Therapeutic Area Lead The Associate Director, Global Clinical Data Standards Therapeutic Area (GCDS TA)-Lead ... the area and/or company.Maintain knowledge of new technologies, industry standards, regulatory requirements, and our Company's guidelines and SOPs.Able to work… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:The TeamThe Regulatory Reporting Technology team is part of the broader Fidelity Brokerage Technology group. As a team we partner closely with ... Fidelity Capital Markets (FCM) to build and maintain regulatory reporting capabilities to meet the strict...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …RoleFinancial Analyst role will report directly to the Vice President of the Regulatory Reporting Group and will be responsible for supporting the group ... detailed processes in a time sensitive environment.The Team The Regulatory Reporting Team is responsible for the...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
