- CHRISTUS Health (Irving, TX)
- …with the goal of increasing service line growth, efficiency, compliance, safety , and patient experience. Responsibilities: Meets expectations of the applicable ... for clinical problem-solving and decision-making. Implements strategies to improve patient safety and outcomes in perinatal care. Uses data to drive decision-making… more
- Aequor (West Greenwich, RI)
- 100% onsite Rhode Island. Admin Shift (7am -3:30pm or 8am -4:30pm) Candidate can select their shift. 8 month duration with possible extension.Ideal: Bachelor degree ... and /or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs ... regulatory packages per International Council for Harmonization (ICH)/Food and Drug Administration (FDA) guidance and provides technical guidance within and outside… more
- Merck & Co. (Rahway, NJ)
- …This includes maintaining lab supply and reagent inventory, ensuring lab safety and cleanliness, coordinating capital budget and equipment procurements for the ... US Associate Director is also responsible for leading lab safety and equipment training for new hires, as well...Company EHS, serving as a liaison and representing senior administration on EHS/chemical hygiene committees. The candidate is expected… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and ... Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration .Ability to work independently and with minimal guidance/oversight.Job duties… more
- Eisai, Inc (Los Angeles, CA)
- …makers within the assigned health systems;Key influencers to possibly include C-Suite and administrative roles within an account (not limited to CEO, CFO, CMO, Case ... visiting accounts to promote sales efforts, and provide clinical, efficacy and safety information on Eisai Oncology brands to key treatment decision makers/executive… more
- Eisai, Inc (Louisville, KY)
- …Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with ... promoted Oncology therapeutic products for specific indications; deliver clinical, efficacy, and safety messaging to target physicians in a compliant way and provide… more
- Eisai, Inc (San Francisco, CA)
- …Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with ... promoted Oncology therapeutic products for specific indications; deliver clinical, efficacy, and safety messaging to target physicians in a compliant way and provide… more
- Merck & Co. (Rahway, NJ)
- …such that the process is scalable without compromising stability, safety , efficacy, and delivery. -During development, we leverage smart experimental ... scalable process, primary packaging, compatibility characterization for processing and administration , and supporting regulatory filings.Collaborate with key stakeholders across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization ... Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... or university)Bachelor's Degree in Computer Science, Life science, Engineering, Business Administration and / or a related discipline requiredMaster's Degree in Life… more
- Merck & Co. (Rahway, NJ)
- …validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in ... and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and equity. Minimum Education… more
- Merck & Co. (Durham, NC)
- …division Quality Manual or with potential for impact on product quality, patient safety or data integrity. Work closely with stakeholders and SME's from site ... change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs (including sufficiently detailed electronic data review/audit trail… more
- CHRISTUS Health (Tenneryville, TX)
- …of customer problems, issues, or concerns . Monitors and promotes workplace safety requirements resulting in positive patient outcomes . Applies systems thinking ... knowledge as an approach to analysis and decision-making . Demonstrates accountability for nursing research and quality improvement activities . Supports provision of evidence-based nursing care . Promotes and communicates patient information effectively… more
- Merck & Co. (Rahway, NJ)
- …characterization such that the process is scalable without compromising stability, safety , efficacy, and delivery. During development, we leverage smart experimental ... scalable process, primary packaging, compatibility characterization for processing and administration , and supporting regulatory filings. Build deep fundamental knowledge… more
- Merck & Co. (Millsboro, DE)
- …of Associate Director.This position will have overall responsibility for oversight and administration of day-to-day operation of the animal facilities as well as for ... biologics manufacturing site.Lead numerous projects including process improvement and safety initiatives.Coordinate / oversee capital projects.Develop and monitor annual… more
- CHRISTUS Health (Youree, LA)
- …provides guidance and direction to medical practice sites to drive patient safety and clinical quality. This role is responsible for implementing policies and ... to minimize anxiety or discomfort. Maintains strict confidentiality and ensures patient safety at all times. Uses oral and written communication skills to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and the regulatory requirements of the US Food and Drug Administration .Job Responsibilities Oversee and Manage Approved and Conditionally Approved Suppliers ... and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policies Perform other duties as assignedRequired… more
- Eisai, Inc (Nashville, TN)
- …dialogue about clinical evidence, approved indication(s), and the product efficacy/ safety profile to support on-label prescribing for appropriate patientsStrong ... Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment… more
- Eisai, Inc (Nutley, NJ)
- …list for Eisai systems eg. eTMF, EDC, IRT Assist with tracking SAE safety reports, collating information and providing updates to the CRO Initiates, tracks and ... Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment… more
