- Merck & Co. (North Wales, PA)
- …Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical Supplies ... Job DescriptionActing as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with… more
- Merck & Co. (North Wales, PA)
- …relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations, ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety... Trials are used to support drug applications and regulatory submissions to health authorities globally.Trial Data Management (TDM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to ... support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities...to ensure SMTs are performing according to necessary ICH/GCP-relevant regulatory requirements and global, departmental and geographical SOPs, policies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and manage GCO… more
- Tris Pharma (Monmouth Junction, NJ)
- … clinical trial investigators and internal scientific, pharmacology and regulatory teamsReviews data generated during study execution to formulate medical ... facility for an experienced MD to serve as Senior Director or Director, Clinical Development. Title and salary commensurate with experience. The position is a core… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk… more
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... and inspection standards, keeping the laboratory in compliance with regulatory standards.Coordinate inventory monitoring, sample, tests to perform and manages… more
- 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 ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems, leveraging technical integrations and ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Merck & Co. (Irving, TX)
- Job DescriptionThis position is responsible for providing technical support to Sales and Marketing for Animal Health products specific to the US Ruminant business, ... the Dairy Industry in TX, KS and NM. Responsibilities include providing technical support for Ruminant products and programs, including response to product inquiries… 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs, and Regulatory Affairs (CMR), staying ... About the Department The Clinical Development, Medical and Regulatory (CMR)...SOPs, KPIs, internal processes; Track and measure specific CMR technical metrics. Work to accelerate innovation across CMR functions… more
- Merck & Co. (Billings, MT)
- Job DescriptionOur Technical Service Managers interact face to face with our customers, understand their needs and consult to offer the right solutions.- We work ... our customer centric business model.This field-based position is responsible for providing technical support to sales and marketing for our company's Animal Health… more
- Merck & Co. (North Wales, PA)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and our ... that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently identifies and anticipates technical or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work closely with cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage ... preparation of the written deliverables that support the clinical development and regulatory requirements of a...or in other settings will be considered Specific or technical job skills: Exceptional written and oral communication skills,… more
- Tris Pharma (Monmouth Junction, NJ)
- …program development (ie, substance use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry ... best practicesOrchestrates and manages clinical aspects of regulatory strategies and actively engages with Food and Drug Administration (FDA) and other … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Non- Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external ... regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position are 1) to ensure the timely execution of biomarker tests on samples from clinical trials and 2) to perform technical and strategic assessment of new and ... clinical sample analysis, archiving of biomarker test results, and regulatory submission activities for Daiichi Sankyo clinical development. 4. Contribute… more
