- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… more
- Aequor (Athens, GA)
- Shift-first Hours- - 7:30am or 8:00am to 4:00pm or 4:30pm The Associate , Quality Control Data will manage the following functions in the Quality Control Department: ... Sample Life Cycle Management in compliance with procedures and regulatory requirements. Responsible as an approved USDA sampler and providing Quality Assurance and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… more
- Insmed Incorporated (Bridgewater, NJ)
- …highly motivated and experienced individual to join our team as the Associate Director of Patient Marketing, focusing on email and performance marketing strategies. ... The Associate Director, Patient Marketing will be a key member...strategies.Set goals, monitor key performance metrics, and provide regular reporting and analysis to stakeholders - highlighting successes, areas… more
- Insmed Incorporated (San Diego, CA)
- …lists.OverviewReporting to the Executive Director of Program Management, the Associate Director, Program Management supports the cross-functional drug development ... project plans for products in accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead and/or participate in special… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This role will work in DX - MARS Team (Metrics, Analytics, Reporting & Solutions) and will be responsible for cultivating a culture of Measurement ... GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and...clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding ... through outsourcing (eg, study startup, study conduct, study closeout, and reporting ).Provides oversight to CRO pertaining to medical coding, coding standards, and… more
- Merck & Co. (Rahway, NJ)
- …organization in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the late ... interests in Product Development Teams (PDT) and Value Chain Management Teams (VCMT). Reporting to the Antibiotics Global Brand leader, the selected candidate will… 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. (WA)
- 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
- 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
- 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)
- …communications for QA, QA projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and… 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
- Novo Nordisk Inc. (Durham, NC)
- …and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise ... for moderate to high complexity issues Responsible for periodic reviews and reporting . Involved with collaboration across sites Update and manage area master data… more
- Merck & Co. (Rahway, NJ)
- …compensation plan.Responsibilities include forecasting, financial analysis, accounting, reporting , compliance, and funding.Primary Activities:Support the ... Job DescriptionPosition Description: Senior Specialist Reporting to the Director, the Senior Specialist Treasury Benefits Finance is responsible for providing… 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
