- Novo Nordisk (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Novo Nordisk (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory... FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee… more
- Gilead Sciences, Inc. (New Brunswick, NJ)
- …to requests for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements + Implements defined goals and objectives ... reporting to a Field Director. The MS will disseminate clinical information about Gilead's innovative hematology and oncology products...aligned with the Medical Affairs Plan of Action and other strategic initiatives +… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- Summary The Biomedical Equipment Support Specialist provides clinical and administrative support to staff, patients, and administrators for all matters of concern ... throughout VA. Responsibilities The Biomedical Equipment Support Specialist provides clinical and administrative support to staff, patients, and administrators for… more
- Novo Nordisk (Plainsboro, NJ)
- …in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory affairs , Patient Safety ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Sumitomo Pharma (Trenton, NJ)
- …for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs ... Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre- clinical research, Medical Affairs...teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA… more
- Novo Nordisk (Plainsboro, NJ)
- …include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. External ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Bausch Health (Edison, NJ)
- …Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical /Medical Affairs , Biostatistics, and Regulatory Affairs . + Lead the ... Responsible for the technical content and timely completion of clinical pharmacology deliverables as well as regulatory ...dermatology drugs is preferred. + Track record of successful regulatory agency (US FDA ) submissions and interactions… more
- Danaher Corporation (New York, NY)
- …within medical device (IVD preferred), biotech, or pharmaceutical + Working knowledge of FDA regulatory requirements related to clinical research + Strong ... and mentorship to Clinical Operations staff.This position is part of the Clinical Affairs department and will be Remote.In this role, you will have… more
- Novo Nordisk (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… more
- Ascendis Pharma (Princeton, NJ)
- …programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential impact ... advocacy groups. + Work with internal stakeholders including Commercial, Legal, Regulatory , Clinical Development, Clinical Operations, Compliance,… more
- Novo Nordisk (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... About the Department The Clinical , Medical and Regulatory (CMR) department...agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention… more
- Bristol Myers Squibb (Princeton, NJ)
- …health and optimize product benefit-risk profiles. The ED works cross-functionally with clinical , regulatory , medical affairs , quality, and commercial teams ... regulatory inquiries. Cross-Functional Leadership and Stakeholder Engagement . Partner with clinical , regulatory , and medical affairs teams to integrate… more
- Novo Nordisk (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… more
- Integra LifeSciences (Princeton, NJ)
- …activities. The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs . **ESSENTIAL DUTIES AND ... and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of… more
- Novo Nordisk (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...and. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Terumo Medical Corporation (Somerset, NJ)
- …NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- Integra LifeSciences (Princeton, NJ)
- …which may include personnel from Engineering, Manufacturing, Product Development, QA, Marketing, Clinical and Regulatory Affairs . + Generate technical ... as part of a cross-functional team (Manufacturing, Design Quality, Regulatory , Quality Assurance, Product Development, Engineering, Facilities, Materials Management,… more
- Fujifilm (Trenton, NJ)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more