- 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
- BeOne Medicines (Emeryville, CA)
- …partnership and collaboration with cross functional leaders/stakeholders (eg Clinical Development, Data Management, Quality , Regulatory ) as it relates to ... PowerPoint and Project).** **Other Qualifications:** **Mid/large pharma experience (preferably clinical operations, process, quality , or compliance roles)**… 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices (GCDMP). This position serves as a key liaison ... Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. + Focus on… 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. (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)
- …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
- GRAIL (Carson City, NV)
- …Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality , or program management ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to… 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
- GRAIL (Menlo Park, CA)
- …and healthcare companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities ... closely with GRAIL study team members to ensure that clinical data captured is complete, consistent, and...system implementation and collaboration with study teams to ensure data quality . + Bachelor's degree required; advanced… 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
- 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
- Parexel (Providence, RI)
- …in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality . Exceptional candidates with 3+ years of ... Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. + Utilize regulatory /product knowledge to provide operational… more
- Stanford Health Care (Palo Alto, CA)
- … Data Analysis and Reporting- Oversee the collection, analysis, and interpretation of clinical data to inform quality improvement strategies.- Prepare and ... a team of Quality Consultant(s), Clinical Nurse Specialist(s), Senior Quality Consultants, and Data Analyst(s) to optimize clinical care services… more
- Lundbeck (Deerfield, IL)
- …active marketed products, by collaborating with cross functional teams during clinical development, regulatory submission and launch. + Supports Lundbeck ... Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location:...of all cross-functional labeling activities to maximize timebound high quality deliverables. + Responsible for the implementation and compliance… more
- Terumo Medical Corporation (Somerset, NJ)
- …and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning ... Sr. Clinical Quality Specialist Date: Nov 19,...strategic input to clinical teams to ensure data integrity, regulatory compliance, and patient safety… 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
- 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)
- …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
- 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
