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Leads an internal Insurance Services team through referral/order receipt, medical record review, benefits investigation, pre-authorization approval and denial appeals and claims preparation and submission.
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Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update.
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Authoring and review of statistical analysis plans and statistical methodology sections in clinical protocols in different therapeutic areas from phase I to phase IV. CR Medicon is a fast-growing Contract Research Organization (CRO) and a platform providing customers with one-stop services for clinical studies of drugs and devices, including Regulatory Affairs, Medical Strategy, Medical Writing, Medical Monitoring, Pharmacovigilance, Clinical Operations, Data Management, Statistical Analysis and Bioanalytical Laboratory.
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It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Responsible for batch record review activities for the site.
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The Associate Director, Regulatory Affairs will review change control for potential impact on client or company submissions, providing regulatory guidance and support for development and production activities, interacting with clients, and maintaining awareness of changes in regulatory requirements for effective regulatory submissions.
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Work with cross-functional project teams (Product Development, Implementation & Support, Research & Implementation, Safety, Regulatory, Legal, Marketing) to review concepts/claims trackers and develop robust clinical programs to support Personal Care, Skin Health products.
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Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound.
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Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL.
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Responsible for the production of clinical supplies Review Literature and gather patent and published articles on the selected projects. On-Board Scientific is hiring a Formulation Scientist based out of New Brunswick NJ.
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The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers.
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Provide high quality input into the design of the clinical study ( including protocol development) and/or clinical development plan (CDP) for early phase project, the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
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Minimum of 5 years medical advisory experience in occupational health, worker compensation, disability, health case management, or utilization review. Using Guidelines, which is the gold standard in clinical guidelines in this industry, the Clinical Case Manager will facilitate medically sound decisions, ensure absence and disability claims are administered effectively, and deliver compassionate care to our client employees.
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Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late stage assets; Assists with development of the Expanded Synopsis and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments.
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Set-up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.) Collect, review and track documents for CA/RA and EC/IRB submissions to confirm the applications are complete before submission and track submissions and approvals for accurate filing in the TMF.
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Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others.
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