- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships with Diagnostic PartnerProvides scientific and technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk ... and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... supported areas by dedicatedly driving compliance.Ensure readiness of records for regulatory inspections and internal audits.Ability to utilize multiple … more
- Merck & Co. (Rahway, NJ)
- …This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in… more
- Merck & Co. (Rahway, NJ)
- …scientific activities on clinical protocols.Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing ... Job DescriptionPosition Description: Associate Director, Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical… more
- System One (Florham Park, NJ)
- Senior Regulatory Operations Associate Contractor (Publishing) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Senior ... Regulatory Operations Associate Contractor The Senior ...managing the lifecycle of submission-related documents. + Conduct final review of published submissions to ensure consistency and compliance… more
- Mizuho Corporate Bank (New York, NY)
- Regulatory Reporting Associate About the Team The Regulatory Reporting Unit files regulatory reports for Mizuho Bank, Ltd. - New York Branch, Mizuho ... to US Basel III at both BHC and legal entity level + P repare and review monthly/quarterly/annual regulatory reports with primary focus on FR Y-15, FR Y-9C and… more
- JPMorgan Chase (New York, NY)
- …and other Corporate Functions to obtain information/documentation to respond to regulatory requests. + Review , analyze, and summarize information/documentation ... with innovation and compliance. As a Tech Risk Engagement Associate in our Cybersecurity and Technology Controls team, you...will contribute to a team that supports the complex regulatory landscape within the firm's risk appetite. Collaborate with… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … activities, and representing Regulatory to cross-functional teams for multiple products. + Experience chairing/leading promotional review committees or ... relevant experience. + For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products. +… more
- Mizuho Corporate Bank (New York, NY)
- …control enhancements. Summary: You will be primarily responsible for testing and validating multiple regulatory reports to ensure that they are prepared in ... Quality Assurance Unit is responsible for enhancing the integrity of the bank regulatory reporting processes, reporting data quality as well as the overall control… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing… more
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director, US Medical, Multiple Myeloma will report to the ... Director, US Medical Multiple Myeloma Asset Lead. He/she will be headquarter based,...US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will support… more
- Publicis Groupe (New York, NY)
- …to output a compliant submission PDF, and annotating pertinent information. + Manage multiple direct reports at the Associate , Senior Associate , and ... stability and experience of a global leader. **Overview** The Senior Manager, Regulatory Promotional Operations, is a subject matter expert specializing in the… more
- Publicis Groupe (New York, NY)
- …of clients) follow the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a key role in establishing ... career development + Provide estimates for SOW development + Work with the Director, Regulatory Review in the development of departmental SOPs + Oversee work of… more
- Publicis Groupe (New York, NY)
- …the stability and experience of a global leader. **Overview** The Manager, Regulatory Promotional Operations, is a subject matter expert specializing in the ... materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. Acting as a brand lead, the...each project through the various stages of the MLR review process. The Manager provides expert guidance on submission… more
- SMBC (New York, NY)
- …will work within the Legal Department and report to the Managing Director, Associate General Counsel. **Role Objectives** + Provide US bank regulatory advice ... trading, and intercompany transactions. + Advise on applications, reports, and other regulatory submissions to US Federal and State banking regulators. + Participate… more
- Principal Financial Group (New York, NY)
- …team in achieving operational readiness. + Financial Statement Preparation and Regulatory Requirements - Prepare/ review financial statements (including balance ... **What You'll Do** We're looking for a Senior Associate to join our Fund Administration, Tax &...analyze, review SEC Yields for assigned funds, prepare/ review data required for various regulatory reporting… more
- L'Oreal USA (Clark, NJ)
- …/ Job Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 187395 Associate Principal Scientist, Cosmetics Product Safety & ... Clark, NJ Research & Innovation Full - Time 01-Sep-2024 Position Title: Associate Principal Scientist, Cosmetics Product Safety & Toxicology, L'Oreal Research &… more