- Novo Nordisk Inc. (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 Inc. (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
- Genmab (Plainsboro, NJ)
- … Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (eg FDA , EMA) A broad knowledge of life-cycle ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the...regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling… 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… more
- Novo Nordisk Inc. (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
- Novo Nordisk Inc. (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
- 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… 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...and. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Tris Pharma (Monmouth Junction, NJ)
- …statistical guidance and support to cross-functional teams including, but limited to: Clinical Development, Regulatory Affairs and Medical WritingManages and ... managers and other stakeholders to ensure data quality and compliance with regulatory requirementsContributes to preparation of clinical study reports, … 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
- 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
- Sanofi Group (Bridgewater, NJ)
- …of US Regulatory strategies (eg, submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts). + Provide ... you will be the primary therapeutic area liaison with FDA 's Office of Prescription Drug Promotion (OPDP) for drugs,...started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising &… 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
- 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
- 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
- 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
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …will also serve as the company pharmacovigilance expert, working in partnership with Medical Affairs and Clinical Affairs teams to bring important drug ... Vice President, Pharmacovigilance is responsible for providing business strategies that support FDA compliant Call Center and Safety data management systems in order… more
