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Acts as legal advisor for assigned corporate business and functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs.
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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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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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They operate a submarine’s sonar, oceanographic equipment, and auxiliary sonar to conduct underwater surveillance, collect scientific data and track enemy targets. Sonar Technician, Submarine (STS) STSs specialize in underwater acoustic technologies.
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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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On-Board Scientific is hiring an Analytical Research and Development Chemist in New Brunswick/Somerset, NJ! Operational and technical expertise on LC-MS, GC-MS and ICP-MS instrumentation. The Analytical Research and Development Chemist will work with an assigned project team of chemists in the laboratory to analyze and develop HPLC and GC methods for assay, impurity and dissolution testing of pharmaceutical finished dosage forms.
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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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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.
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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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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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Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program. Certificate of Clinical Competence in Speech-Language Pathology (CCC-SLP) is required.
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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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The RBD role requires a unique set of skills that demands both clinical knowledge, on-label scientific expertise, customer interface team management and leadership skills to provide education and support to providers and patients in the region.
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Provides medical and/or scientific direction to Clinical Operations. 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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Englewood Hospital, a community teaching hospital founded in 1890, consistently earns high marks for clinical excellence and patient safety. Areas of clinical excellence offered by the health system include cardiac surgery and cardiac care, cancer care, orthopedic surgery, primary care, spine surgery, vascular surgery, and women’s health, as well as bloodless medicine and surgery and minimally invasive robotic surgery.
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clinical scientific affairs jobs Company: Regeneron Pharmaceuticals Inc in Bridgewater, NJ
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