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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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Maintain and continue to enhance knowledge about HEOR methods and the evolving public health policy and reimbursement environment in major (USA, Europe and Japan) and other pertinent marketsLead team to ensure cross-functional collaboration between Global Market Access and Pricing and other internal stakeholders such as Medical Affairs, Clinical Development, Marketing, Biostats, etc.
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As a Research Scientist, you will work on exciting skin care development. Collects, evaluates and communicates all data collected internally and externally from stability, efficacy and clinical testing and collaborates with Regulatory towards global registration, claims and Quality compliance.
$100 - $114,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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New Jersey's academic health center, Rutgers Biomedical and Health Sciences (RBHS) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health.
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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.
$150,000 - $510,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director, RPM provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in RPM processes and suggesting and integrating operational and procedural excellence best practice into RPM processes to enhance regulatory affairs capabilities.
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Research and development areas encompass oncology, cardiovascular and metabolic disorders, retina, immunology, neuroscience, and infectious disease. Your role will involve applying state-of-the-art AI techniques to extract valuable insights from various image modalities such as OCT (optical coherence tomography), FAF (fundus auto-fluorescence), and CFP (color fundus photography) in diseases such as dry AMD and IRDs. Through the use of these innovative technologies, you will improve our understanding of structural biomarkers during disease progression, ultimately enhancing clinical trial efficacy and efficiency.
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Own the end-to-end architecture of the modern Safety/Pharmacovigilance Data Platforms which ingests data from the several systems across clinical, non-clinical systems and transforms it into insights for internal and external users using a scalable big data pipeline on Google Cloud Platform.
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Desired Qualifications: B.S or M.S. Degree in Civil Engineering Licensed Professional Engineer (PE), or (EIT) 3+ years of demonstrated engineering design of Land Development Projects Utility Design Site Grading Storm Water Management Systems Zoning Research Permitting Research Proficiency with AutoCAD, Civil 3D software Salary and Benefits: Comprehensive Salary Package.
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Ashland has an exciting opportunity for a Scientist/Staff Scientist to join our research and development (R&D) group for medical device related products in the Diagnostic Film Group at our Bridgewater, NJ location.
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Currently Hiring for Clinical Psychologist, LCSW, LSW, LMSW, LMHC, LMFT,LMHC located in NJ, NY, PA, or MD. Clinical Psychologist (Ph. D, Psy. D, or EdD) Previous clinical experience in Skilled Nursing, Hospital, Hospice, or Home Care setting is a plus.
$110,000 - $145,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). Extensive experience in medical affairs/post-approval area and execution of project user requirements, system design, validation plans, operational and performance protocols, research, and development of applications and toolkits for end-users.
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Licensed Clinical Social Worker (LCSW)/ Licensed Marriage and Family Therapist (LMFT) / Licensed Professional Counselor (LPC). Woodcliff Lake, Parsippany, Brick, Eatontown, Piscataway, North Brunswick, Mt Laurel, Lyndhurst and Bernardsville, NJ area who are passionate about patient care and committed to clinical excellence.
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It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Be responsible for providing quality oversight for site Quality Control laboratories responsible for testing pre-clinical and clinical and commercial stage CAR-T cellular therapy products in accordance with Janssen policies, standards, procedures, and Global cGMP.
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clinical research affairs jobs Title: director Company: Regeneron Pharmaceuticals Inc in Bridgewater, NJ
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