Collecting information
Organizing data
At Roche you can show up as yourself, embraced for the unique qualities you bring. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys immunoassay product portfolio. You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
Collaborate with marketing to review and approve product marketing claims, ensuring compliance with FDA regulations and guidelines.. Collaborate with the quality team to ensure that the company's Quality Management System (QMS) meets regulatory requirements and is effectively implemented.. Review complaint decision trees and handle regulatory reporting of events.. Work closely with R&D, Quality, Marketing, Clinical, Market Access, and other departments to align regulatory activities with business objectives.. 7+ years of experience in regulatory affairs within the medical device industry, with a focus on U.S. FDA submissions and clearances.
Regulatory Affairs Manager - Bilingual (Mandarin & English)Regulatory Affairs Manager - Bilingual (Mandarin & English). Get notified about new Regulatory Affairs Manager jobs in San Diego, CA. Associate Regulatory Affairs Manager (San Diego). Senior Regulatory Affairs Manager (Onsite)Regulatory Affairs Associate Director or Senior Manager. Staff Regulatory Affairs Specialist - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid) - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid)
This Sr. Analyst, Healthcare Analytics role will be responsible for work around Program Valuation on Molina's Risk Adjustment Actuarial team.. Performs Health Plan strategic analysis and planning and coordinates across business units on Risk Adjustment Program Valuation and Strategic/Scoreable Action Items (SAIs) to meet business needs.. Compiling and organizing health care data using Databricks and Spark SQL, Notebooks, Workflows, Repositories, SQL Server Stored Procedures, SQL Server Integration Services (SSIS), and other analytic / programming tools as needed. Develop and demonstrate proficiency in running all applicable risk models including the various CMS models for Medicare Advantage members, the HHS model for Commercial ACA members, the CDPS model for Medicaid members, and others as needed. Analysis and forecasting of program value and underlying population trends in risk adjustment to provide analytic support for finance, pricing and actuarial functions
Big Data Engineer - Medicare/Medicaid at Molina Healthcare in Caldwell, Idaho, United States Job Description Job Summary We are seeking a highly skilled and forward-thinking Big Data Engineer to join our healthcare data team.. - Build and manage batch and real-time data ingestion/extraction pipelines using tools like Kafka, Spark Streaming, and Talend.. - Enforce data quality, security, and compliance standards using tools such as Kerberos, Ranger, and Sentry.. - Expertise in Big Data tools: Spark, Hive, Impala, Presto, Phoenix, Kylin, and Hadoop (HDFS, YARN).. HEOR (Health Economics and outcomes Research) - Prior experience working in the healthcare industry with familiarity in clinical, claims, or care management data.
We are seeking a highly skilled and motivated Clinical Research Nurse to join our team on a full-time basis, working Monday through Friday, day shift. As a Clinical Research Nurse, you will collaborate with a multidisciplinary team to coordinate clinical trials and provide exceptional patient care. These studies serve patients in specialties such as cardiology and CV surgery, pulmonology, transplant, neurology, GI, endocrinology, and infectious diseases. The research nurse position allows the team member to utilize their nursing knowledge and skills through the coordination of clinical trials. The clinical research nurse achieves this by coordinating regulatory aspects of clinical trials, collaborating with team members and key stake holders both within and outside of IU Health, screening and enrolling patients in clinical trials and carrying out study visits.
Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation.. The Senior Manager, Clinical Quality Assurance (CQA) is responsible for ensuring that clinical trials are conducted in accordance with applicable regulatory requirements (e.g., GCP, FDA, EMA, ICH), company SOPs, and industry standards.. Develop, implement, and maintain GCP compliance programs / procedures and quality systems to support clinical trial execution.. Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Therapeutics, CMC and other departments to support study execution and regulatory readiness.. Familiarity with electronic systems (eTMF, EDC, QMS, Veeva Vault, etc
Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.. Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.. Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines.. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Senior Manager of Translational Pharmacology at Mirum, responsible for the General Pharmacology, Animal Efficacy, PK/PD, ADME, Bioanalytical, Translational Biomarker, and related studies required for further development and approval of Mirum rare disease assets.. Outsources nonclinical and bioanalytical studies, reviews resulting pharmacology and biomarker data, and reports to check for completeness and accuracy and communicate to teams. Provides CROs with technical oversight as needed and ensures that assay development, validations and data transfers occur at CROs and in-house to meet project goals. Previous experience with immunology of the liver and/or neurology preferred, especially in the context of rare disease. Deep knowledge of pharmacology and biomarker study design and interpretation, pharmacodynamics, and pharmacokinetics modeling
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection.. Oversees Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems.. Get notified about new Regulatory Affairs Manager jobs in Boca Raton, FL.. Associate Director, Regulatory Affairs - Plasma Services. Research Regulatory Affairs Specialist I
Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline with 10+ years of regulatory affairs experience in the biotech/pharmaceutical industry, including 5+ years at the Director level or above.. Proficiency in regulatory operations, including working with publishing vendors and eCTD submissions.. Provide regulatory guidance on special designations (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) and expedited pathways, as applicable.. Support regulatory activities related to CMC, nonclinical, and pharmacovigilance to ensure comprehensive submission packages.. Biotechnology Research and Pharmaceutical Manufacturing
Regulatory Affairs Manager. LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location.. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week.. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.. Experience serving as a Regulatory Affairs Manager performing:Laboratory and facility inspections in support of GLP studiesFacility audits as required by GLPsQMS audits of ISO/FDA elementsRegulatory agency inspectionsGCP trainingGCP compliance auditsInternal and external current GMP audits
With more than 2,000 licensed beds, we are also proud of our role as the primary teaching hospital for the University of Miami Miller School of Medicine.. The Director of Regulatory Affairs is a member of the leadership team who is responsible for the organization-wide oversight and resolution of regulatory and hospital licensure matters including process changes, new requirements, and compliance with all regulatory standards required for patient safety and quality of care and services and promotion of continuous survey readiness.. Collaborates with Risk Management in the facilitation of root cause analysis (RCA), failure mode and effects analysis (FMEA) and monitoring of action plan implementation.. Collaboration with Risk Management in relation to incidents that may result in regulatory visits and/or sentinel event reporting.. The leader to report through any of the reporting mechanisms (e.g., anonymous hotline, supervisor, Compliance Officer) any suspected health care fraud, waste and/or abuse as well as other compliance-related issues.
Senior Regulatory Affairs Associate. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers.. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.. The Senior Regulatory Affairs Associate works with faculty and staff in the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues.. In partnership with the PI, prepare and track all clinical activity documents including IRB/IBC/site registration approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the companys strategic objectives. Provide strategic guidance and regulatory support for the design and approval of nonclinical studies and clinical trials. Prior experience with European regulations (MDR). Significant experience in leading and preparing major international regulatory submission projects and supportive amendments or supplements, and interfacing with regulatory authorities. Experience in analysis, interpretation and extraction of important concepts from engineering/technical specifications and data, scientific information, international standards and government regulations
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.. Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU.. Creates and implements CMC regulatory strategies for CTA submissions and marketing applications.. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans.. BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
This is a management position responsible for coordinating the quality assurance program for Monroe Community Hospital.. Quality assurance involves all hospital functions such as patient care, equipment, confidentiality issues, and customer satisfaction, among others.. Work involves providing technical assistance to hospital staff to assist them in meeting quality assurance objectives.. The incumbent reports directly to and works under general supervision of the Deputy Director of Monroe Community Hospital or other higher level staff members.. Professional for the purpose of these minimum qualifications does not include secretarial, clerical or similar experience.
Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.. Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.. Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines.. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Under the direction of the Quality Assurance Project Manager, the Quality Assurance Manager will work to ensure the Clinical Trial Organization (CTO) established standard processes and procedures are being followed and maintained.. Along with the QA team, the QA Manager provides quality control support, assistance and direction for clinical trials supported by KUCC or where KUCC is a participating site.. Perform internal audits of the Investigator Initiated Clinical Trials (IITs) conducted at The University of Kansas Cancer Center to ensure protocol compliance, and adherence to Clinical Trials Office Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable Institutional and Regulatory guidelines and requirement(s).. Interact with Pharmaceutical company sponsor Quality Assurance auditors, Clinical Research Organization (CRO) auditors Cooperative group nurse auditors, and other academic institution QA teams in the scheduling, preparation and hosting of external audits both onsite and remote.. Ensure the effectiveness of The KUCC Quality Assurance team by establishing positive and professional relationships with the KU Cancer Center Principal Investigators, Clinical Trials Office staff including CTO Leadership, Senior Management, Project Management, Clinical Research Coordinators, Clinical Research Data Coordinators, KU Health System staff members and maintain these relationships through constructive and non-punitive communication.
The Director of Regulatory Affairs will lead BodyBio’s regulatory strategy and execution across all product categories, including dietary supplements, functional foods, and international expansion initiatives.. Oversee label revision controls, including claim language, allergen declarations, country-of-origin labeling, and documentation.. Guide company adaptation to Bill 96, including French language requirements for product packaging, marketing, and websites.. Texas Christian University Trial (including paperwork review and IRB coordination). 5+ years experience in regulatory affairs within the dietary supplement, functional food, or natural health product industries.