- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... industry ) is preferred1 or more years of industry experience within regulatory is preferredOrganized and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions. This role is the primary CSPV contact for Good ... Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/ Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of Novo ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...Director - Accelerated Efficiencies and Optimization, Strategic Operations. The Project Manager regularly works with members of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team ... Carvykti program. Specifically, this effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and company policies and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of new reporting systems.Establish and implement programming standards and comply with regulatory requirements among project team members and across all ... well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... assesses these requirements, creates compliant processes and provides advice to project functional teams, as needed. Proactively identifies and manages risks.Builds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Visio, Power Point), training systems, and metrics dashboarding preferred- Understanding of industry trends (eg, regulatory , technology) with ability to apply ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... etc., under the direction of Director, Compliance Policy, Training and Communications. Project manage various teams to build creative training programs from… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Insmed Incorporated (Bridgewater, NJ)
- …and want to work with the most dedicated people in the biopharma industry , come to Insmed to accelerate your career. RecognitionsNamed Science's Top Employer in ... That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.A Certified Great Place to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key ... Team Leaders.Responsibilities- Creating and leading a high performing, cross-functional global project team composed of representative of asset through the lifecycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mapping tools (eg, Visio, Power Point), and Veeva Quality Docs requiredUnderstanding of regulatory and industry guidance and updates, with ability to apply them ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with...PhD 0- 2 years relevant experience in the pharmaceutical industry with Ph.D. in statistics or biostatistics or equivalent… more
- Amazon (New York, NY)
- Description The Senior Project Manager , Dangerous Goods (DG) Regulatory Engagement is a DG subject matter expert (SME) responsible for planning, coordinating ... and engaging with regulatory bodies and industry to influence DG...- 3+ years' experience with a track record of project deliverables in the regulatory compliance space… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible...) is preferred + 1 or more years of industry experience within regulatory is preferred +… more
- Motion Recruitment Partners (New York, NY)
- Senior Regulatory Project Manager New York,...work alongside some of the smartest minds in the industry who are excited to share their knowledge and to ... NY **Hybrid** Contract $80/hr - $86/hr Grow your career as a Senior Regulatory Project Manager with an innovative global bank in New York, NY. Contract role… more
