- Merck & Co. (Rahway, NJ)
- …Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining ... engages with leadership across the GRACS organization and collaborates with internal and external functions such as our company's QA, GCD Standards, and Learning &… more
- Merck & Co. (Rahway, NJ)
- …with colleagues from Formulation Sciences, Device Development, Quality, Regulatory Affairs , Engineering, and Analytical will be required to ensure effective ... skills.The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply.- Primary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including study design,… more
- Merck & Co. (Rahway, NJ)
- …plans and develop a global view of policy priorities for GPP. The Executive Director will direct development of internal and external policy positions on ... across the policy function and work with the AVP, Strategic Planning & External Engagement leadership team (LT) and Director , Strategic Operations Team to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Market Access, Immunology T he Director , Global Market Access, Immunology will play a leadership role in ... strategy for assets within our Immunology portfolio. In this role, the Director will lead the development and execution of global market access strategy,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary US Medical Affairs leader for assigned compound under the supervision and leadership of the ... Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops the USOMA strategy and tactical plan as part of the US Brand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of ... the Senior Director , GMA Oncology ADC (Global Medical Affairs ...medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs , Evidence Generation role is ... the Alliance Partner.- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs ...plans for delayed activities. Ensure that appropriate internal and external communication is current and clear. Ensure communication of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs , Evidence Generation role is ... Outcomes Research partner.- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs ...plans for delayed activities. Ensure that appropriate internal and external communication is current and clear.- Drive the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …state government affairs strategy and engagement. Contributes to internal and external advocacy and educational materials and provides support to leadership in ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meetings. This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position also interacts with other therapeutic ... throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ... labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease ... of review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback from the regional strategists in terms of HA meetings globally. Responsible… more
- Merck & Co. (Rahway, NJ)
- …talented and dedicated colleagues while developing and expanding your career.--The Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… 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...the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a… more
- Merck & Co. (Rahway, NJ)
- …selected for this role will work under the guidance of the Executive Director , ESG Strategic Consulting in a fast-paced and changing environment.-The ESG Strategy & ... is part of Our Company's Social Business Innovation (SBI) department within Corporate Affairs . In addition to ESG, SBI includes teams focus on health equity, global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Medical Affairs (GMA) Oncology- Medical Content and ... responsible for execution of global scientific and training deliverables. The Associate Director develops and executes Medical Content and Training plans and works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross ... activities as needed. ResponsibilitiesCollaborate with Global and Regional Medical Affairs , co-development company and various cross functional teams to develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing… more
