- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to gather ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key...(GRA) Process Excellence function, responsible for driving data governance, reporting , and analytics for RA. This will include working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …number of projects /studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects /studiesProject ... Position manages end-to-end delivery of data management services for assigned projects /studies, collaborating with CROs and other vendors to ensure high quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ... our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM could be responsible for a… 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 operations team for the site.- The Manager will direct a team of hourly personnel who are accountable for the 24-hour operations of the site.- The Manager… more
- Novo Nordisk Inc. (Boulder, CO)
- …experienced professionals or support staff Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …As a member of the Total Rewards CoE, the Global Employee Shares Manager will be responsible for managing and administering the company's global employee share ... Americas Lead certain areas of share plan administration such as financial reporting , recharge process, and tax compliance Collaborate with Legal and Finance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to ... ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology… 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
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …GSA, Federal, HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… 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)
- …financial position of the Company in order to provide meaningful support.Provide project management support for special Compliance projects which may include ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… 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
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... and summary reports for submission to the FDA and International Regulatory authorities.Interface with other Eisai Departments and affiliates for dissemination of… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... in place to execute the plan Ensure tracking & reporting of KPI's Ensure knowledge transfer & alignment with...members & other teams Ability to lead task & project teams Ability to manage a changing work environment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting ) and the systems that support ... skills Excellent project management skills to oversee and drive project execution Ability to manage multiple projects concurrently and collaborate… more
- Eisai, Inc (Nutley, NJ)
- …Facilitate Project Steering Committees in collaboration with Business Owner and Project Manager . Represent business needs to the broader EIT organization ... IT Operations. Partner with ITQA, Business Owner and IT Project Manager for defining a master validation...budgets forecasts in partnership with Finance. Communicate financial and project status of projects to MDC Planning.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …fits into the larger corporate narrative.- Oversee media monitoring reporting and tracking KPIs- Ensure internal corporate communications department procedure ... corporate communications colleagues as needed to plan and manage assigned projects - Build, collaborate and maintain strong network of cross-functional and… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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)
- …providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data ... skills in working in a fast-paced environment, continuous improvement, project management, change and risk management. Responsibilities - Leadership, Direction,… more
