- Insmed Incorporated (San Diego, CA)
- …leadership within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project ... industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product ... This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory ...with Medicines Australia's Code of Conduct. Support phase 3 clinical trials by managing CTNs and liaising with the… 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
- Merck & Co. (Rahway, NJ)
- …processes, including relevant standards and documentation. - Familiarity with FDA Good Clinical Practices, ICH Guidelines, and other major regulatory agencies' ... experienced and highly motivated individuals to join our team for a Clinical Operations Educator position. As- Clinical Operations Educator you will… more
- Merck & Co. (Upper Gwynedd, PA)
- … development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior ... --Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff… 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
- Jooble (Port Arthur, TX)
- …Education/Skills Bachelor's Degree or higher in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited ... equivalent to a US Bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology OR Meets the educational… more
- Jooble (Caddo County, LA)
- …Education/Skills Bachelor's Degree or higher in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited ... equivalent to a US Bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology. Experience No experience required… 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
- Insmed Incorporated (San Diego, CA)
- …closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC ... technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all phases of clinical developmentTeam… 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… 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 ... Engineering or related field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science , Statistics, Applied Mathematics, Life… more
- Merck & Co. (Rahway, NJ)
- …people from diverse background and expertise, including research scientists, clinical scientists, regulatory experts, IT specialists, etc.Identify opportunities ... responses to data and analysis related queries from research scientists, clinical scientists, and regulatory agencies.--Engage in AI/ML and statistical… more
- Merck & Co. (Boston, MA)
- …(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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced… 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 ... join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early… more
