- Novo Nordisk Inc. (Plainsboro, NJ)
- …externally (eg, KOL interviews, literature assessments, benchmarking, landscape assessments, financial analyses, regulatory policies) providing insight and ... 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… more
- Aequor (TX)
- …NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of ... regulatory support, review and approval of applications with the...Support the NB Budget process and processing of NB financial invoicing. Actively contribute to the delivery of internal… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …utilize prior academic experience to optimize resource allocation, ensure regulatory compliance, and uphold rigorous scientific standards. Understanding best ... ensure research projects are executed efficiently and effectively, and within budget. Regulatory Oversight: Uphold the highest standards of quality and compliance… 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)
- …play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you ... also educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental safety, integration of new/existing ... technologies, customer service, resource utilization, financial performance and fiscal stewardship. GENERAL PROFILE Demonstrates leadership and provides direction to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across the pipeline portfolio, the Lead ... Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs, analytics, and other relevant NNI departments to define… more
- Merck & Co. (Durham, NC)
- …lead the operations team to deliver the facility startup, process validation, regulatory submission, PAI, and ultimately the commercial manufacture of the product's ... quality product at a competitive cost and consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… more
- Merck & Co. (Durham, NC)
- …a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing ... daily deadlines; develops plans to meet short-term objectives.Works within budgetary/ financial objectives set by Director.Makes decisions guided by policies and… more
- Eisai, Inc (Nutley, NJ)
- …and value to support medical development, additional (post approval) regulatory and safety needs.Ensure communication/publication strategies for given products and ... appropriate and accountability driven throughout the organization.Direct and manage financial planning/forecasting and budget management, vendor management, timeline development… 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)
- …project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input ... orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well as… more
- Tris Pharma (Monmouth Junction, NJ)
- …of opportunities, evaluation from a strategic, commercial, scientific, and financial standpoint, and execution (due diligence, negotiation, etc.). She/he will ... of in-license/M&A opportunities: analyze market and competitive landscape, assess financial and overall potential, determine strategic fit, outline strategic… 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
- Insmed Incorporated (San Diego, CA)
- …goals and input to the global product strategy Facilitates resource planning, financial , and capacity assessments as needed Documents issues, decisions, and action ... with proven management and/or leadership experience in an R&D, Regulatory , manufacturing/operations or commercial context in a biotech/bio-pharmaceutical environment… more
- Insmed Incorporated (Bridgewater, NJ)
- …HCP Agency of Record.Work closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs, to align and compliantly execute ... work.Work closely with the financial business partner to manage spend to budget.Ensure culture of compliance.Qualifications:Bachelor's degree required; MBA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and ... e-mail- Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (eg tracking of expenses for travel and office… more
- Insmed Incorporated (San Diego, CA)
- …management in strategic planning, capabilities development, projections, and other financial issues.Initiate and implement plans, develop and improve areas of ... and inspection standards, keeping the laboratory in compliance with regulatory standards.Coordinate inventory monitoring, sample, tests to perform and manages… more
- Eisai, Inc (Exton, PA)
- …are for products from pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will ... or commercial production is highly desired.An understanding of project accounting and financial concepts is also required since this individual will participate in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities in accordance with the strategic targets Support budgeting and financial coordination across the department Lead meeting coordination and stakeholder ... of market needs and demonstrated understanding of legal and regulatory environment of pharmaceutical industry Demonstrated analytical skills. Capability to… more
