- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... Technology . The incumbent must be able to work well...integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist of Device Technology Assessment and Early Development will spearhead early-stage device technology evaluation ... and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in assessing the viability of new concepts and drive early… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated ability to identify, mitigate… more
- Merck & Co. (Rahway, NJ)
- …activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing ... investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ... we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.-The Distinguished… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient ... regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in ... standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and… more
- Merck & Co. (Rahway, NJ)
- …our Inventors. Using innovative thinking, state-of-the-art facilities, cutting-edge science, and technology , we partner to deliver the next medical breakthrough. We ... development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific… more
- Merck & Co. (Rahway, NJ)
- …Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology , we collaborate to deliver the next medical breakthroughs. ... investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... experiments aimed at achieving research goals related to process development, technology development, and production of active pharmaceutical ingredients (API).- The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of post-law school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
