- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) ... oversight and supervision of the TA-Head or CRD.Requires understanding of local regulatory environment.Scientific and clinical research knowledge is… more
- Novo Nordisk Inc. (Atlanta, GA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director, Clinical Outsourcing is from :157,200-206,300Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Merck & Co. (North Wales, PA)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development Statistics, ... eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Catalent (St. Petersburg, FL)
- Associate Scientist II, Analytical Research & Development Position Summary Catalent is a global, high-growth, public company, and a leading partner for the ... services to solve difficult development and manufacturing challenges. The Analytical Research and Development (AR&D) laboratory that supports evaluation and testing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… 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 ... agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in… more
- Insmed Incorporated (Bridgewater, NJ)
- …purchase orders, payment tracking and process for external parties.Strong knowledge of clinical research process, including working knowledge of all functional ... experience in a Clinical Operations Experience considered relevant includes clinical and/or basic research in a bio/pharmaceutical company, Academic … more
- Tris Pharma (Monmouth Junction, NJ)
- …or skills needed and/or licenses or certificates preferred:Advanced degree (MS, MPH, PhD, PharmD, etc.) Clinical Research Associate (CRA) or Clinical ... aspects of the development, oversight and execution of phase I to IV clinical research trials. Collaborating closely with Physicians, Clinical Leaders… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... and our company's guidelines and SOPs.Required Experience:5+ years of work experience in pre- clinical and/or clinical research to include minimum 2 years'… more
- Merck & Co. (North Wales, PA)
- …including conflict resolution expertise and discretion.Preferred: Cross-functional experience in clinical research (eg, monitoring, data management, clinical ... critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation & Adaptive Integrated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Principal Scientist, Small Molecule Research & DevelopmentIn your role as Associate Principal Scientist, you will be part of a team ... imaging tools, and data analysis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities,… more
- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety, contract research organizations ... our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
