- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and… more
- Insmed Incorporated (San Diego, CA)
- …to help prepare for inspections is required.Experience developing SOPs, reviewing internal clinical , regulatory and medical processes to ensure they are ... industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... Dermatology, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science , Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research ... leadership and functional capability to keep pace with the changing science and regulatory environment.Establishing and effective implementation and oversight… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) ... Science , Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance, Regulatory Documents {+ 4 more}-Preferred Skills:Job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, procedural ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in ... Role OverviewAs part of the US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to ... a high-performing organization that:Attracts and cultivates essential skills needed for data science and AI, ensuring the team remains at the forefront of industry… more
- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on operational management… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… 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 ... or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science , Statistics, Applied Mathematics, Life… more
- Merck & Co. (North Wales, PA)
- …Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Physiology, Regulatory Compliance, Regulatory ... software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial...of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The… more
- Merck & Co. (North Wales, PA)
- …managing any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... Life Science , Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Science {+ 4… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or… more
- Merck & Co. (South San Francisco, CA)
- …License:NoHazardous Material(s):n/aRequired Skills: Clinical Development, Clinical Pharmacology, Clinical Trial Designs, Data Modeling, Data Science , Data ... ms of experienced sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and ophthalmologic diseases. You… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), pediatrics modeling and disease progression… more
