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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Successful applicants will instruct undergraduate or graduate level courses in at least one of the the following content areas:-School Counseling and Counseling Psychology-College Student Affairs and Higher Education-Educational Psychology: Learning & Cognition and/or Human Development-Gifted Education-Special Education-Educational Statistics, Measurement, and/or EvaluationCourses will be offered in a range of modalities beyond traditional settings, including hybrid and online formats.
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We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. 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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Provide direct one-on-one or small group ABA therapy sessions, focusing on areas such as communication, social skills, self-care, and academic support. The role involves working closely with students to improve communication, social, and adaptive skills, as well as collaborating with the educational team to support each student's academic and behavioral success.
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Must have run and managed RWE and RWD programs in large pharma companies Must have managed a team of 10 people Knowledge of medical affair, scientific affairs and HEOR are preferable Excellent communication and collaboration skills Detailed Job description: Lead the coordination and execution of RWE projects including RWE analytics to address medical gaps within Global Integrated Evidence Generation Plans (IEGPs.
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The Robert Wood Johnson School of Medicine is consistently ranked as one of the highly NIH-funded academic universities and Rutgers is a member of the Association of American Universities comprising the top research universities in North America.
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The Outcomes Research Stats Analyst/ Statistical Programmer will report to the Director of Data Analytics OR of Medical Affairs Outcomes Research. Experience working with medical and billing coding systems such as ICD-10, SNOMED, LOINC, NDC, HCPCS, CPT.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Easily accessible around the world, Azenta is the preferred partner at leading academic, pharmaceutical, biotechnology, agricultural, government, and clinical institutions. AZENTA is a leading global genomics service company and trusted provider for DNA sequencing, gene synthesis, molecular biology, next generation sequencing, bioinformatics, and GLP regulatory services.
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7 or More Years in regulatory affairs. Advanced degree (e.g., Masters, PharmD., Ph. D., MD, JD) preferred. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
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As the Regulatory Affairs Manager, you will play a crucial role in making a significant impact on public health and contributing to the successful access of innovative therapies for the LATAM population, being part of a team that values excellence, collaboration, and continuous learning.
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A substitute paraprofessional assists the classroom teacher to provide extra support to students with special needs, promoting maximum academic and personal growth. Attend to students' physical, personal, academic, and emotional needs.
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Support and manage the creation/revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation (e.g., Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals.
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RWJBarnabas Health is the premier health care destination providing patient-centered,high-quality academic medicine in a compassionate and equitable manner, while deliveringa best-in-class work experience to every member of the team.
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academic affairs jobs in Plainfield, NJ
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