- Nesco Resource (Woodland, CA)
- Scope of Position:Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality ... quality metrics for site.Responsible for new product setup, quality project management , and regulatory compliance of serum products.Ensure compliance to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... including regulatory and/or compliance area and experience with process management in a regulated environment.Master's Degree and a minimum of 8 years… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Affairs interests on cross-functional teams including, Field Medical Affairs , Medical Operations, Clinical Trial Management , HEOR, Market Access, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ... adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in...the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management , Quality Assurance, Medical Affairs , ... Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive strategic business partnership with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management , Quality Assurance, Medical Affairs , ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, Clinical Trial Management , and Clinical ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …new technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... and KOL strategists reporting to them. Essential Functions Brand/Therapy Area Management : Defines the pre-launch / launch HCP-related brand/therapy area strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Merck & Co. (Rahway, NJ)
- …to work with all levels of management within and outside of-Global Regulatory Affairs and Clinical Safety (GRACS).Interact closely with the system owner for ... cultural differencesPreferred Experience and skills: Five years' experience in Pharmacovigilance/ Regulatory /CMC/ Quality /ClinicalNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs , and other RD functions to ensure ... Business Management )Partner and collaborate with global marketing, global medical affairs , global payers and access and commercial business units to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Affairs , HEOR, Future Business Strategy, Commercial, Account Management , Analytics, Legal, Regulatory , Investor Relations, Value Communication and ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …close collaboration with other functional areas such as biostatistics, data management , clinical operations, pharmacovigilance, regulatory affairs , etc. ... related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs ' externally sponsored clinical research ... management setting requiredA robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively… 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 at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
