- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …successful completion of major programs or initiatives, and may function in a project leadership role Regulatory compliance: Ensures compliance with all Federal ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...review and vendor management support in regards to safety reporting . To serves as a liaison between NNI Patient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , IT Project Portfolio Management (IT PPM) is expected to contribute ... trends and improvement areasStreamline and work with program and project managers to facilitate their regular reporting ...training Project Managers on the use of project management systems, processes, and templates The Manager… more
- Novo Nordisk Inc. (Boulder, CO)
- …change. Are you ready to make a difference? The Position Experienced Project Manager that can manage complex projects within budget, on time, & within scope. ... Manage multiple projects simultaneously. Ensure projects are executed & staffed according to ...all requirements (quality, cost, schedule). Responsible for monitoring & reporting project progress, communications to management &… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or ... TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with-ICH/GCP and… 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
- Merck & Co. (Durham, NC)
- …scheduling, staffing, protocol execution)Coach team members in executing smaller improvement projects in their operational areaRepresent Operations on project ... Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide… more
- Merck & Co. (Rahway, NJ)
- …to make decisions independently with limited oversight from Sr.COM or manager .Requires strong understanding of local regulatory environment.Ability to ... company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs, Regulatory , Privacy, Sales, and Legal. Will also interact with NNA/S on ... international omnichannel projects and outside organizations as required. Essential Functions Customer Database Management - Healthcare Professional Database:… 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)
- …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. (Atlanta, GA)
- 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
- Novo Nordisk Inc. (Boulder, CO)
- …environmental, health, and safety policies, procedures and practices Maintain internal and regulatory reporting including data collection and reporting ... and fire codes Serve as onsite contact for all regulatory agencies for inspections, permitting, reporting (eg,...with Scientists, Managers, Supervisors and employees Keep the Facilities Manager and Human Resources Manager up to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …creation of basic reports and presentations, providing support for budgets and projects , and system reporting and processing. Relationships Requires frequent ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...The incumbent's work is not dependent on the department manager ; rather, he/she typically spends the majority of their… more
- Aequor (Seattle, WA)
- …the site. Generate document management system reports for Quality Council metric reporting . Support internal and external audits and regulatory inspections if ... Job Description: Top Skills: - 2&plus years of Document Control & Reporting Experience, - Veeva experience preferred - Technical troubleshooting - Self motivated,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …applicable department equipment and techniques related to job function, and regulatory requirements for the operation of the area Support evaluation, specification, ... Support, Engineering, EH&S, and OE as directed Serves as project member or project leader on improvement...Supports manufacturing activities in other departments as instructed by manager Performs all job duties and responsibilities in a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending. Possess signature authority for deviation closure Reviews… more
