- BeOne Medicines (Trenton, NJ)
- …Excellence plays a pivotal role for driving the successful execution of Global Regulatory Operations Strategy & Innovation programs and projects in a dynamic ... required. + 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations related experience preferred. **Computer Skills:** High… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position The Specialist, Regulatory Operations - Submissions supports the development of submission plans created ... submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal departments on … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide...your potential with us? The Position The Regional Security Manager US Ops position has responsibility for the development,… more
- Insmed Incorporated (NJ)
- …all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and oversight of regional trial activities, as ... assigned.Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters.Effectively manages and/or assists with cross-functional clinical study team members to achieve deliverables with high quality, on time,… more
- Insmed Incorporated (NJ)
- …all stages of product development, including Research, Preclinical, Clinical, Regulatory , Operations , Quality Assurance.Innovative thinking and an ... we're in. Are you?About the Role:Reporting to the Director of Technical Operations , Project Management this position will be responsible for leading life-cycle… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position We are seeking a detail-oriented and passionate Training Manager to join our Clinical, Medical, Regulatory (CMR) group at Novo ... Functions Create job-specific training curricula for different roles within clinical operations , medical affairs, and regulatory affairs Maintain training… more
- ValSource, Inc. (Rahway, NJ)
- Project Manager ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be responsible for preparing and… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (San Diego, CA)
- …management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... Control Assessments, Upgrade and Patch assessments, Release assessments. Manage day-to-day operations of the CSV function including managing CSV system folders in… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.- - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Durham, NC)
- …skills (instrumentation, electrical and mechanical Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations ... Effective maintenance, troubleshooting, and problem-solving skills Working knowledge of regulatory requirements in accordance with GMP manufacturing operations… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... Control Assessments, Upgrade and Patch assessments, Release assessments. Manage day-to-day operations of the CSV function including managing CSV system folders in… more
- Aequor (Parsippany, NJ)
- Job Title: Senior Procurement Manager - Marketing & Sales Indirect Procurement North America Position Summary: This position will report to the Director, Global ... company policies, industry standards, and legal regulations. Liaise with Legal, Regulatory , Finance, IT and other functions as needed. Education: Bachelor's degree… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Baltimore, MD)
- …and compliance with company standards and governmental regulatory requirements. Investigates/troubleshoots equipment/instrument issues and/or performance processes. ... coordinate calibration activities to support ongoing compliance, validation activities, operations activities, maintenances schedules, new equipment/instrument installations, daily production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Manager , Site Indirect Procurement as part of the Supply Chain team based in ... Raritan, NJ. Role OverviewThe Manager , Site Indirect Procurement, will be responsible for supporting and executing all Indirect Procurement activities at the… more
- Merck & Co. (Biloxi, MS)
- …and technologies but also through our people. As a Sr. Corporate Account Manager (Poultry Health) you will serve as the internal hatchery technical expert and ... products. This position is a field based technical services manager position within the US Poultry Business Unit and...event reporting in accordance with internal, FDA and USDA regulatory policies, dealing with bird health issues in customer's… more
