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BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Title: Scientific - Global Regulatory CMC Manager.
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The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.
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Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents.
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Under the supervision of a project leader or a senior scientist, perform laboratory work to support scientific discovery programs related to skin biology. Ability to design antibody panels for multi-color flow cytometry.
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Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
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Strong academic credentials, including a bachelor’s or graduate level degree in a relevant scientific background; a license to practice before the USPTO or substantial intellectual property practice experience, preferably in Hatch-Waxman and BPCIA litigation; extensive knowledge of the Hatch-Waxman Act, the BPCIA, and related regulations and practices.
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Requirements: BS/BA degree in Scientific Discipline (Masters or higher preferred) with - years in the pharmaceutical industry, preferably with - years CMC regulatory experience. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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HEDS is part of our company's Biostatistics and Research Decision Sciences group, and works in collaboration with internal and external partners (such as the Center for Observational and Real-World Evidence, CORE) to generate the evidence to support scientific and commercial value of our company's portfolio to optimize access, reimbursement, and patient outcomes.
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The Grant Writer serves in a key role to provide advising, writing, and a full range of substantive editing on scientific research proposals, manuscripts, and other written products. The incumbent is responsible for supporting scientific writing for grant applications (to federal funding agencies, non-profit funding organizations, and foundations, as well as university intramural opportunities.
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PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
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Translational Medicine Hematology at BMS has a long-standing history of scientific rigor as evidenced by our peer-reviewed publications, delivery of drug approvals including Revlimid, Pomalyst, Idhifa, Inrebic, Reblozyl, Vidaza and Onureg, strong academic collaborations and talent development.
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This group integrates scientific learnings from the lab and clinic as well as business insights of multiple functions and leads the development of translational strategies at the franchise level.
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You have the power to build, manage, and develop a team of highly competent and engaged managers in the areas of Medical and Scientific Affairs, Medical Information and Pharmacovigilance. You will develop and execute the U.S. Medical and Scientific Affairs strategy and execution, policies, programs and SOPs; oversee Investigator Sponsored Trial (IST) programs.
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2+ years experience with installation, performance maintenance, troubleshooting, support and/or end user utilization of scientific instrumentation, preference for previous TA Instruments product suite (DSC, TGA, SDT, TMA, and DMA.
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As a Field Service Specialist working for an industry leader, you'll join a global team of specialists that are committed to ensuring TA Instruments' legendary service for our customers who utilize our scientific instrumentation and software.
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scientific job Company: New York City Police Department in Kenilworth, NJ
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