- TrackFive (Wichita, KS)
- …patient information, maintaining patient safety, and upholding ethical standards in compliance with healthcare regulations. Additionally, the review may consider ... to your inbox every day when you wake up Medical , Dental, and Vision Insurance 401k with Employer matching...Los Angeles County Fair Chance Ordinance, FlexCare conducts a review of criminal history after a conditional offer of… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Siemens Healthineers (Florence, SC)
- …in determining the appropriate imaging techniques for each patient. Maintain compliance with all regulatory standards, including radiation safety guidelines ... part of a team that's at the forefront of medical advancements, making a real difference in patient care...information, procedure details, and imaging results accurately in the medical records system. Ensure proper labeling and storage of… more
- PandoLogic (St. Charles, MO)
- …and overseeing key elements of the HSE Management System, with a focus on regulatory compliance , risk management, and sustainability. With a focus on promoting ... executed. Ensure required regulatory reports, permits, surveys, regulatory fees, and compliance plans are completed...Business Continuity Plan (BCP) for a 24/54 operation. Manage compliance with federal and state medical surveillance,… more
- TrackFive (Wichita, KS)
- …procedures, medications administered, and outcomes. Ensure patient records are in compliance with institutional and regulatory standards, including HIPAA ... TravelNurseSource is working with Magnet Medical to find a qualified Other RN in...appropriate treatments are delivered. Participate in patient rounds to review and update care plans as necessary. Infection Control… more
- Merck & Co. (North Wales, PA)
- …in the promotional review and label update processes and collaborate with the Medical Legal Regulatory Review teams to find solutions and make ... ongoing support to job owners and agency partners on promotional review processes and systems, help job owners navigate complex situations, conduct… 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 ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data quality and proactive detection and resolution of issues.External Engagement:Continuously review compliance metrics trends from regulators/ industry experts ... pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical ...QMS framework (ie, Quality Management Review , Quality Review Board) across the global medical affairs… more
- Novo Nordisk Inc. (San Francisco, 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Merck & Co. (Rahway, NJ)
- …Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance , Regulatory Inspections, Vaccine ... Divisional and Regional Quality/Management councilsProvide guidance and consultation services for regulatory reporting (eg, BPDR, DPR)Author and/or review global… more
- Eisai, Inc (Nutley, NJ)
- …initiatives as needed.Manage and support the review of SEM and internal medical documents through Medical Review Committee according to company ... & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review ,… more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... enhances data-driven decision-making. -Ensure the clarity, accuracy, and conciseness of regulatory documents to facilitate the review process. -Implement… more
- Merck & Co. (North Wales, PA)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical , Data Coordination,… more
- Merck & Co. (Durham, NC)
- …methodologies, including statistical process control, deepening process understanding Author, review , and/or edit technical documents to support regulatory ... to meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...MSL managers. Develop congress abstract tracker, assign MSL coverage, review MSL reporting responsibilities, collate and distribute Congress Report,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute… more
- Merck & Co. (Durham, NC)
- …Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Merck & Co. (Rahway, NJ)
- …state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... investigators.-Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.Participates with management in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor ... and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
