- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Novo Nordisk Inc. (Phoenix, AZ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Merck & Co. (Rahway, NJ)
- …Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...prevention activities as process improvement and training, as needed. Education :- Bachelor's degree or equivalent in relevant health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,... programs. Requirements PhD strongly preferred but combination of education and experience may be considered in lieu of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses ... in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory… more
- Eisai, Inc (NJ)
- …experience in pharma or related industry OR equivalent combination of education and experienceExperience writing/reviewing clinical regulatory documents and ... want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Atlanta, GA)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product, and its approved indications,...hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree in ... Experience Qualifications- Eight (8) plus years of pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in a regulated… more
