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Years of mainframe experience in IBM JCL, CA, JCL, and utilities, COBOL, REXX, EasyTrieve, VSAM, IDMS, Endevor, File Master, Dispatch, View, UniTech and Remedy utilities. years of mainframe experience in IBM JCL, CA, JCL, and utilities, COBOL, REXX, EasyTrieve, VSAM, IDMS, Endevor, File Master, Dispatch, View, UniTech and Remedy utilities.
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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.) Pharming is seeking to hire a Clinical Trial Assistant (CTA) to bring general administrative support to the Clinical Operations Department and assistance to Project Manager(s), Clinical Project Coordinator(s) and Department Manager/Director(s) on the various tasks associated with conducting clinical trials.
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The Candidate: Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience Master of Science in Analytical Chemistry/Pharmaceutics preferred or more years of applicable industry experience in support of pharmaceutical product development Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Resolves problems causing payer denial or failed Medicare edits as they involve the charge master. Educates HMH departments and physicians with respect to the use and maintenance of the charge master and charging philosophy.
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Design and execute formulation trials, analytical testing and evaluate stability data to finalize formulation composition for RNA/gene-based therapies. Insight Global is looking for a Formulation Chemist to join the research group for one of our pharmaceutical clients in Bridgewater, NJ. This person will focus on targeted non-viral formulation development for RNA/gene-based therapies.
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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Develop and file, in tandem with the General Counsel and the Compliance Office, mandatory insurance regulatory filings related to ERM, including but not limited to the Enterprise Risk Report and the Own Risk and Solvency Assessment (ORSA) Summary Report.
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The research portfolio of the Dermatology Service includes optical engineering, artificial intelligence, basic science, translational science, epidemiology and clinical trials with over $5 million of annual funding from NIH, Foundations, Industry, and philanthropic sources.
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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Trial experience, with a track record of success in the courtroom. Draft and file legal documents necessary for personal injury cases, including complaints, pleadings, and motions. Prepare and present cases for trial, including selecting jurors, arguing motions, meeting with judges, and presenting evidence.
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This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
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Preferred certifications are Project Management Institute’s (PMI) Project Management Professional (PMP) certification, Lean, Six Sigma, ITIL, COBIT, Certified Scrum Master (CSM), Certified Scrum Product Owner (CSPO), Certified SAFe Scrum Master (SSM), Advanced Project Manager Certification (APMC.
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Certifications/Licenses Required Knowledge, Skills, and Abilities Equipment Utilized Physical Demands and Work Environment Overview The Master of Business & Science degree (MBS) is a degree combining the science curriculum from a traditional science master’s degree with a specialized set of business+ courses – including business, policy, and law.
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Responsibilities and Requirements: Organize clinical trial data (e.g., integrate EDC datasets to analyze data, generate descriptive summaries, etc.) This role will require someone who is creative & resourceful in researching and "grabbing " R packages from the open-sources and at least 3-5 years of clinical trial development experience.
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trials trial master file jobs Title: trial master file in Middlesex, NJ
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