- 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. (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
- 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
- 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
- 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
- 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
- University of New Mexico - Hospitals (Albuquerque, NM)
- …UNM Hospital. In this impactful, data -driven role, you will partner with clinical teams to improve workflows, support regulatory readiness, and elevate ... Analyst, you will : * Review and interpret quality and operational data to help identify... teams. * Assist with educating Radiology staff on quality standards, safety practices, and regulatory requirements.… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of National Advisory Board meetings, at the discretion of Executive Director) Deliver clinical data and other presentations at National Advisory Board meetings ... About the Department The Clinical , Medical and Regulatory (CMR) department...gain feedback from advisors Support other advisory boards with clinical data and other medical presentations Partner… more
- Novo Nordisk Inc. (Minneapolis, MN)
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …cross-function teams to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable ... products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. The role will… more
- Merck & Co. (North Wales, PA)
- …and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead the CRO and vendor ... study team in end-to end delivery of the clinical trial with consistency, quality and per...standards and timelines and that quality of data is suitable for regulatory submission. The… more
