- Merck & Co. (Rahway, NJ)
- …pipelines) and relevant systems (LIMS, MES, SAP). Experience in data governance, data stewardship, and data quality management in regulated environments. ... sections, enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation.- - - Under the… more
- Eisai, Inc (Raleigh, NC)
- …Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. ... will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Good Clinical Practice (GCP), Nursing, Patient Education, Quality Management, Quality Standards, Regulatory Compliance, Regulatory ... in any GCTO footprint country Required Skills: Adaptability, Adaptability, Business Processes, Clinical Data Management, Clinical Research, Clinical … more
- Insmed Incorporated (NJ)
- …timelines, submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs, CMC, Clinical , Quality ) to facilitate ... future of science, we're in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to help us expand what's… more
- Merck & Co. (Rahway, NJ)
- …Inclusion.Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting ... the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed… more
- Merck & Co. (North Wales, PA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines… more
- Insmed Incorporated (NJ)
- …one compound to ensure all are delivered on time, within budget and with high quality . This role may manage clinical operations team members, as delegated by ... to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents … more
- Merck & Co. (Boston, MA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential... Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Data… more
- Insmed Incorporated (NJ)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and ... studies, reviewing & interpreting clinical trial data , authoring clinical study and regulatory...may affect the quality and integrity of clinical studies.Perform medical monitoring, coding, and data … 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 ... serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Insmed Incorporated (San Diego, CA)
- … clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well as ... reporting of results Provide scientific input and review of clinical study data , support in assessing medical...of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR,… more
- Genmab (NJ)
- …with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity Directly supports knowledge ... data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. Responsibilities Develops… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities ... clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study protocols,… 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 ... Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality , Legal, Privacy and Finance. External relationships… more
- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... appropriate identification, evaluation, and management of risks associated with product quality . Build strong relationships with regulatory agencies and other… more
- Insmed Incorporated (NJ)
- … documents from large volumes of scientific information.Experience presenting drug safety topics, clinical and safety data to regulatory authorities, health ... of products in development. You'll also:Be responsible for appropriate review of all safety data from various sources (eg pre- clinical , clinical trial … more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (North Wales, PA)
- …project level Position Specific Required Skills and Experience: Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic ... in CDISC SDTM and ADaM standardsSignificant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPHDesigns… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … more
