- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support … 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
- Merck & Co. (Rahway, NJ)
- …Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, develops, and ... and/or delivery challenges or unrealized opportunities to better satisfy patient/user/ market need.Principal ResponsibilitiesAlongside the device project lead, lead 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 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …management.Anticipate, recognize, and respond to changing internal and external trends, market conditions, regulatory legislation, etc., evaluate and integrate ... site, regional and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance… 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)
- 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)
- …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)
- …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)
- …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)
- …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. (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)
- …plan alignment. Other internal relationships include those with Medical, Sales, Regulatory , Legal, Market Access, Global Marketing and Global Medical. ... 5-year time horizon. This department serves as the insiders of the US market when informing and help shaping upstream decisions around future investments and assets.… more
