- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study… more
- ProClinical (Nutley, NJ)
- …including study sites, clinical vendors, and internal processes. Oversee and review results of clinical quality assurance audits. Facilitate sponsor ... - Permanent - New Jersey (Hybrid) Proclinical is seeking a Director of Clinical Quality Assurance (GCP) to lead the design, delivery, and execution of … more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP… more
- UnitedHealth Group (Phoenix, AZ)
- …preferably in a clinical quality consultant role 2+ years of clinical data abstraction/ quality chart review experience Billing and CPT coding ... of care. Join us to start Caring. Connecting. Growing together. The Sr. Clinical Quality Consultant RN will drive consistency, efficient processes and share… more
- Kaiser Permanente (Baldwin Park, CA)
- …position is also responsible for providing consultation and education related to clinical quality and patient safety, accreditation, regulatory and licensing ... License (California) Additional Requirements: Knowledge, Skills, and Abilities (KSAs): Clinical Quality Expertise; Negotiation; Business Process Improvement;… more
- Merck & Co. (Rahway, NJ)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Merck & Co. (Rahway, NJ)
- …on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data/medical protocol deviations in collaborations with ... protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... multiple and complex cross-functional projects with many stakeholders.Support other quality systems activities, as needed.Support drafting, review and… more
- Family Health Centers of San Diego (San Diego, CA)
- …diversity of our staff. Family Health Centers of San Diego is looking for a Clinical Quality Analyst to work under the supervision and direction the Director of ... and Innovation. You will provide data and analytical support to the Clinical Quality Committee and its workgroups as assigned. Responsibilities: Responsible… more
- Edgewise Therapeutics (Boulder, CO)
- Senior Director/Executive Director, Clinical Quality Assurance About Edgewise Therapeutics: At Edgewise, we are on a mission to discover new medicines that ... leader to serve as Senior Director or Executive Director, Clinical Quality Assurance (CQA) (level to be...and support clinical teams. Represent QA on clinical study teams, ensuring review and approval… more
- BioSpace (Boston, MA)
- …the best of my knowledge. Job Description About the role: The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the ... teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and...trial delivery in partnership with GDO, PSPV, GRA etc. Review the outputs of the safety and clinical… more
- Merck & Co. (Rahway, NJ)
- … Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and ... supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. -Responsible and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Genmab (NJ)
- …of our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities ... us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart...meetings, and lead review cycles.Provide expert peer review and editing support to elevate the quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Marshall Health Network (Huntington, WV)
- …individual will also serve on the Metabolic and Bariatric Committee (MBC) for continuous quality improvement. The Clinical Reviewer will be required to have ... Cabell Huntington Hospital is seeking a temporary full-time Bariatric Clinical Reviewer for the Bariatric Surgery Department. The Clinical Reviewer will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to ... processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of.../ our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Clementine Programs (West Linn, OR)
- …join the Clementine team. The Clinical Director is responsible for the overall clinical quality of our treatment program. This includes, but is not limited ... genetics, disability, age, or veteran status. Responsibilities Include: Ensure overall clinical quality of programming with continuous improvement, staffing, and… more
