- Novo Nordisk Inc. (New York, NY)
- 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)
- …a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects.Gain endorsement from ... appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan ... or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more… 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 ... performance against metric targets.Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.Lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Merck & Co. (Rahway, NJ)
- …be able to work with all levels of management within and outside of-Global Regulatory Affairs and Clinical Safety (GRACS).Interact closely with the system owner ... Job DescriptionUnder minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management… more
- Merck & Co. (Rahway, NJ)
- …multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as external partners (diagnostic ... across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and ... diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead...Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.Job Summary The Director is responsible for developing strategies for assigned product(s) and execution of HEOR and ... products, interfaces with cross-functional teams including marketing, market access, and medical affairs to align strategies, and partners with HEOR field team in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,)...colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... distribution, promotion etc.Deep knowledge of the pharmaceutical Legal, Medical, Regulatory review processDemonstrated experience in driving marketing strategy … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical ... Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring strict...strategic goals and compliance standards from initiation through completion.Operational Strategy : Develop and implement ESR team operational strategies for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and… more
