- 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
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... that delivers reliable, high- quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory , Quality Assurance, and cGMP requirementsHigh energy, innovative "can do" ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the… 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 (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good...discretion and latitude required in the role, and external market and internal value when determining a salary level… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Catalent (Harman, WV)
- … regulatory SOP and cGMP guidelines.Manages processes to optimize quality performance and on-time delivery to insure customer satisfaction.Establishes annual ... Senior Director , Supply Chain Position Summary: The Senior ...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... commercial insights and analytics, Privacy, Legal, Compliance, marketing, Market Access, Pricing Contracting Ops and Reimbursement, Finance, IT, etc. Other internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …of 7 years of pharmaceutical industry experience in HEOR and/or market accessKnowledge of pharmaceutical and regulatory guidelines on development ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , HEOR leads the strategic planning and execution of HEOR evidence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …testing new/future opportunities. Relationships This position reports into the Sr. Director , Omnichannel Engagement and is responsible for managing the Consumer ... will interact with enterprise consumer brand teams, Global Marketing, Corporate Communications, Market Access, Medical, Sales, Legal, Compliance & IT, as well as the… more
- Insmed Incorporated (Bridgewater, NJ)
- …for statistical aspects of clinical development plans, studies, submission activities and regulatory interactions.Manage the timelines and oversee the quality of ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Biostatistics is a highly visible role within the Clinical… more
- Insmed Incorporated (Bridgewater, NJ)
- …modalities.Assure bioanalytical tasks are executed to high scientific standards, with quality , and within agreed timelines. This entails overseeing work by internal ... in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical aspects for complex ... execution, analysis and reporting of clinicals.Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.Undertake new and highly… more
- Catalent (St. Petersburg, FL)
- …accordance with templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and the ... and prospective suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements in...from early development to clinical trials and to the market . Catalent produces more than 70 billion doses per… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This position is primarily responsible for activities related to safeguarding the quality of all product released for market in the United States. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality . Regularly interfaces with multiple… 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
- Novo Nordisk Inc. (Milwaukee, WI)
- 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)
- …execute projects and capability enhancements. Relationships Reports to the Director , NextGen Customer Engagement. Provides direct support to Omnichannel Engagement ... such as Marketing, Field Execution, Field Systems, Advanced Analytics, IT, Legal, Regulatory , as well as external vendors. Essential Functions Enable the NextGen… more
- RWJBarnabas Health (Somerset, NJ)
- Director Regulatory Planning - Somerset, NJReq #:0000142324 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health Corporate ... Jersey Department of Health ( DOH ), Internal Revenue Service, CMS and other regulatory agencies. The Director will work collaboratively and have a front facing… more
- Olympus Corporation of the Americas (Westborough, MA)
- …(VAI, OAI etc.) with regulatory agencies as well as working with Post Market Quality in fulfilling routine requests for information with regulatory ... compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and...of the Global Quality System with applicable regulatory requirements and with the business strategy of the… more
