- 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
- Tris Pharma (Monmouth Junction, NJ)
- …will apply model-informed drug development (MIDD) principles to support translational science and clinical development plans from first-in-human through late ... pharmacodynamics, and exposure-response modeling and will collaborate closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs… more
- Merck & Co. (Rahway, NJ)
- …Respect - Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the ... Sciences, Clinical Site Management, Clinical Study Design, Clinical Trials Operations, Computer Science , Design, Detail-Oriented, Ethical Compliance,… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology data as it relates to safety and efficacy.Contributes to Clinical Pharmacology expertise and content to regulatory documents (eg briefing ... a Clinical Pharmacology Project Lead.A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational Medicine… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data… more
- Legend Biotech USA, Inc. (Detroit, MI)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Medical Science Liaison as part of the Medical Affairs team based in Great Lakes ... & IL). Role OverviewAs part of the US Medical Affairs team, the Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GDIM to drive technology-enabled process improvements. Build strong relationships with clinical development, clinical sciences, regulatory , biostats, data ... 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)
- …the future of science , we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... leadership within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project… more
- Takeda Pharmaceutical (Boston, MA)
- …TA leaders on regional specificities within Therapeutic Area.ACCOUNTABILITIES: Accountable to Oncology Clinical Science Head to provide strategic clinical ... and Medical Monitor of record for assigned compounds.Oversees and leads all clinical science activities involved in interactions with FDA, other … more
- Insmed Incorporated (NJ)
- … regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with ... meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive...Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve… more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation… 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 ... meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive...Are you?About the Role:Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical … more
- Merck & Co. (Rahway, NJ)
- …Knowledge:In-depth understanding of Autoinjector design, manufacturing processes, and regulatory requirements.Familiarity with materials science , particularly as ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …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. (Rahway, NJ)
- …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
- Insmed Incorporated (San Diego, CA)
- …collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.What You'll ... technical expertise and system documentation.Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development.Team… more
- Merck & Co. (Rahway, NJ)
- …deliverablesProduce SAS transport files and associated documentation for regulatory submissionsEducation and Minimum Requirement:BA/BS in Computer Science ... or related field plus 5-9 years SAS programming experience in a clinical trial environmentMS in Computer Science , Statistics, Applied Mathematics, Life… more
- Insmed Incorporated (NJ)
- …team members to align and compliantly execute key tactical activitiesCollaborate with Regulatory , Supply Chain, and Clinical colleagues to ensure compliant and ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as… more
