- Genmab (NJ)
- …global regulatory requirements.RequirementsBachelor's degree in a scientific, technical, or health -related field; advanced degree (MS, PhD) preferred.Minimum of 10 ... experience in clinical data management, clinical operations, or other related clinical research experience with at least 3-5 years in data oversight and leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The ... personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoringFor studies in which… more
- Eisai, Inc (Raleigh, NC)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the… more
- Merck & Co. (Rahway, NJ)
- …Exchange Excellence), Omnichannel, ACE (Analytics Center of Excellence), our Company Research Laboratories, and HH IT, and Legal and Compliance, to oversee ... SLs.Experience leveraging emerging technologies such as AI, machine learning, digital health platforms, and advanced analytics to drive innovation in medical… more
- Genmab (NJ)
- …program and/or study.Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, including health authority ... we thrive on connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients… more
- Merck & Co. (Deforest, WI)
- …Husbandry, Business, Customer Experience Management, Customer Service, Field Sales Support, Health Outcomes, Herd Health , International Travel Arrangements, ... Job DescriptionOur Company's Animal Health division is the world leader in the...attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is… more
- Eisai, Inc (Nutley, NJ)
- …clinical study inspections from preparation through resolution with various Health Authorities.Communicate complex research ideas and insights to ... to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company...in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of… more
- Merck & Co. (North Wales, PA)
- …standards beyond 2025 ( ie IDMP related activities and submissions to Global Health Authorities ) . Th is will result in positioning the Company competitively ... a leader in advocating with trade, consortia and as appropriate with Health Authorities to promote harmonization and adoption of global standards around regulatory… more
- Eisai, Inc (NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the… more
- Merck & Co. (Durham, NC)
- …review, and CBER submissions.Create batch specific documentation such as Health Authority monitoring reports or release-specific shipping documents, and prepare ... software versions.Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.-A high degree of problem-solving ability.Must have… more