- 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Merck & Co. (North Wales, PA)
- …mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead ... Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under...groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness of submissions.Resolve complex project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will...to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... a Job Summary: The position will define and oversee the translational strategy /plan for oncology therapeutic program/s in global R&D. The successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... 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
- Tris Pharma (Monmouth Junction, NJ)
- …deliverables as per project priorities. She/he also reviews and approves all scientific , technical and regulatory packages per International Council for ... (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , AR&D serves… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... on assignment) with demonstrated decision-making capabilities Provides medical and scientific expertise to cross-functional DSI colleaguesResponsibilities- Medical Monitoring- For… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a ... Biologics and Biopharmaceutics leadership and extended leadership teams to implement strategy , conduct scientific research, step across boundaries and resource… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the creation of the development strategy ensuring the highest scientific /medical standards in accordance with ethical and regulatory requirements across ... 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
- 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. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible for: Providing scientific and medical ... on scientific questions relevant to his/her areas of responsibility. The Director is responsible for maintaining a strong scientific fund of knowledge… 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... centered around rare diseases and immune disorders. Summary Sr. Director Data Management contributes to the vision, direction and... Data Management contributes to the vision, direction and strategy for Data Management globally and executes the … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy : Clinical study leader (CSL) or major scientific /medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... Development in Project Teams, possibly as Global Clinical Lead. Responsibilities:Study Strategy : Clinical study leader (CSL) or major scientific /medical… more
- Merck & Co. (Rahway, NJ)
- …Asset/ brand strategy development.Provide commercial inputs, where appropriate, into Scientific Strategy development & execution (eg, Congress Planning, ... while supporting local needsParticipate in the development of customer engagement strategy and scientific expert leader engagement.Through detailed competition… more
