- Tris Pharma (Monmouth Junction, NJ)
- …of relevant work experienceBachelors degree or equivalent in a scientific or health care field and minimum 3 years clinical research experience (including ... and written) Special knowledge or skills needed and/or licenses or certificates preferred: Advanced degree (MS, MPH, PhD, PharmD, etc.) Clinical Research Associate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the application of those principles to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies with… more
- Novo Nordisk Inc. (San Francisco, CA)
- …years' experience in a health-related system, pharmaceutical company, or managed care environment required Relevant clinical and/or therapeutic experience ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies with… more
- Eisai, Inc (NJ)
- …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 ... Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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. (Boston, MA)
- …Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...with ambiguity and embrace uncertainty. The role will demand critical , timely, independent decision making and requires a high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nurse (RN) or Bachelors degree required (in science-related discipline preferred). Advanced knowledge of Good Clinical Practice (GCPs), ICH Guidelines, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies with… more
- Merck & Co. (North Wales, PA)
- …for stakeholders as needed.Build and maintain excellent relationships with clinical investigators, scientific leaders, external authors, journal editors, and ... management experience at or supporting -pharmaceutical/biotech companies related to the clinical development processAt least 2 years of experience in publication… more
- Eisai, Inc (Nutley, NJ)
- …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 ... the capabilities of the Sales Team through initial product training, advanced product training, improved selling skills, disease state knowledge, clinical… more
- Merck & Co. (Rahway, NJ)
- …analy sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include: - Driving solutions to analytical ... well as methods for the re lease and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings. - Providing analytical leadership… more
- Merck & Co. (North Wales, PA)
- …(MCRP) previously called Global Medical Information Physician (GMIP) for Oncology provides clinical expertise and advice to internal stakeholders and is a member of ... Affairs Teams. In PRT, the MCRP is responsible for ensuring the clinical relevance and medical accuracy of data/information in promotional materials, external… more
- Merck & Co. (Rahway, NJ)
- …pharmacology, vaccines, and biologics in conjunction with functional area and clinical development leadership. Contribute to the business development strategy within ... biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in conjunction...to ensure relevant deals of highest priority are being advanced and executed timely. Manage a portfolio of complex… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory, market access, manufacturing, CMC, commercial, and other areas) ... as applicable to the project.Building and maintaining project schedules and critical project information in enterprise project management systems and databases;… more
- Merck & Co. (Rahway, NJ)
- …data analysis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities, which are in no particular order and ... as well as methods for the release and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings.Author investigational new drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... and proposed plans to address either/both in a timely manner- Clinical Development and Regulatory Support and Leadership for given indication(s)/tumor(s):- Represent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission documents (eg, IBs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior ... America and Global organization. Manages external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants.… more
- Merck & Co. (South San Francisco, CA)
- …research conducted in our new laboratories spans exploratory biology through early clinical development and is an integral part of our powerful world-class network ... highly motivated and exceptional scientist with a focus on advanced AI/ML approaches for small molecule modeling in the...with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. -This Hybrid work… more
