- 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. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Merck & Co. (Rahway, NJ)
- …Preclinical and Translational Medicine, Global Medical and Scientific Affairs , and Global Regulatory Affairs and Clinical Safety to identify key issues ... and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects and… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Taiho Oncology (Princeton, NJ)
- …regulatory activities for Taiho Oncology, Inc., (TOI), with general guidance from manager and regulatory affairs leadership. + Fosters collaborative, ... Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA...incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- …currently recruiting for one Supervisory Health System Specialist (Credentialing and Privileging Manager ) for the Chief of Staff service at the Manhattan Campus ... location. The C&P Manager serves as the VAMC's Senior Technical Advisor and...and effectively accomplishing quality work that is compliant with regulatory requirements and procedures, TJC standards, laws, and VHA… more
- Mount Sinai Health System (New York, NY)
- …experience (preferred: research or regulatory ); MS degree or advanced certification in regulatory affairs or clinical research is preferred + 3 years ... Description** This individual will report directly to the Medicine Clinical Trials Office (MCTO Research Manager to...Regulatory Coordinator will be responsible for supporting the regulatory affairs team to ensure compliance with… more
- RWJBarnabas Health (Somerset, NJ)
- Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health ... the Department through establishing, tracking project milestones and coordinating submissions. Manager assists in obtaining regulatory approval for enterprise… more
- Hackensack Meridian Health (Neptune, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... mission to transform healthcare and serve as a leader of positive change. The ** Manager , Clinical Research Center Operations** is responsible for Clinical … more
- VNS Health (Manhattan, NY)
- …of member UAS-NY for potential new members and existing members' conditions clinical , environmental, and social to establish an individual plan of care needed ... requests for services from providers, members, and care management team and renders clinical determinations in accordance with VNS Health Plans policies as well as… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Sumitomo Pharma (Trenton, NJ)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Edwards Lifesciences (Trenton, NJ)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Fujifilm (Trenton, NJ)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more
- Terumo Medical Corporation (Somerset, NJ)
- …(DSS) Program Manager will work closely with NA Marketing, Sales, Field Clinical , Medical Affairs , Supply Chain and TC teams to understand the established ... Dual Sensor Program Manager Date: Dec 27, 2024 Req ID: 3487...and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients.… more
- Integra LifeSciences (Princeton, NJ)
- …brochures and seminars + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... patient outcomes and set new standards of care. **Global Senior Product Manager ** Reporting to a Senior Director, Global Marketing - Codman Specialty Surgical,… more
- Integra LifeSciences (Princeton, NJ)
- …brochures and seminars + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... trimming, forecasting, pricing strategies, literature/video/sales support materials, labeling revisions, clinical studies, manufacturing and customer service/operations support for existing… more
- Integra LifeSciences (Princeton, NJ)
- …presentation and communication of product information. Reviews all materials with Marketing, Regulatory , Medical Affairs , and legal team to confirm the standards ... for product line extensions, literature/video/sales support materials, labeling revisions, clinical studies, and commercial operations processes and tools supporting… more
