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Author Jobs in New Jersey

1 - 15 of 70
1 - 15 of 70
Search Results - Author Jobs in New Jersey
Experic LLC-Cranbury
and process development, and author the associated protocols.  •  Manage experimental activities, with the potential to assist in hands-on execution.  •  Receive and analyze analytical, physicochemical, and manufacturing data using statistical tools, mathematical...
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Medix™-North Plainfield
and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements.  •  Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata...
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Hengrui Pharma-Princeton (NJ)
functionally with Process Development, Drug Product Development, Manufacturing, Quality Assurance (QA), Regulatory Affairs, and Project Management teams.  •  Participate in regulatory submissions and inspections; author or review CMC sections of Investigational...
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Hengrui Pharma-Princeton (NJ)
functionally with Process Development, Drug Product Development, Manufacturing, Quality Assurance (QA), Regulatory Affairs, and Project Management teams.  •  Participate in regulatory submissions and inspections; author or review CMC sections of Investigational...
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SOFIE-Totowa
Initiate and author Investigations, CAPAs, Deviation, and Change Control documentation as related to manufacturing of drug product including samples generated for testing of radiopharmaceuticals.  •  Follow and observe all radiation safety procedures...
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US Tech Solutions-Raritan (NJ)
Cycle Management projects.  •  Act as Subject Matter Expert for one or more validation categories. Leverage the global MSAT network to identify and implement best practices.  •  Author and review well-documented protocols and reports for all processes...
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HUTCHMED-Florham Park
on the clinical/commercial viability of products and factors into planning.  •  Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.  •  Lead & author relevant sections...
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North Star Academy Charter School-Newark
students grapple with open-ended guiding questions, engage in peer-to-peer debate, and synthesize arguments.  •  You'll guide students to understand the author's claim and the power of sourcing while developing the skills of argumentation, corroboration...
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esrhealthcare-Paramus
DESCRIPTION: Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Support...
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Macpower Digital Assets Edge Private Limited-Paramus
development, manufacturing, and quality control to deliver high-quality eCTD submissions. Key Responsibilities: Regulatory Documentation & Submissions:  •  Author/review CMC sections of regulatory dossiers (eCTD Module 2.3 & 3) for US-FDA (IND, BLA, NDA...
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Talium Advisors-Princeton (NJ)
trainings for state and district personnel  •  Authors, edits, and manages ongoing client and stakeholder communications and customer relations management tools Basic Qualifications:  •  1+ years of related experience  •  Ability to recognize and described...
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Camden Prep, Inc.-Camden (NJ)
Instruction  •  You'll empower students to be their fullest selves by teaching an inclusive, culturally responsive curriculum that seeks equitable outcomes for all students.  •  You'll guide students to analyze literary and non-narrative texts, assess an author's...
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Adecco-Morristown (NJ)
quality documentation standards. Pay: $50- 56/hr based on education and relevant experience level Key Responsibilities:  •  Author and develop CMC sections of regulatory dossiers (Modules 2 and 3) for development and post-approval submissions.  •  Draft...
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KPMG-Montvale (NJ)
with other groups in WNT  •  Instruct internal firm courses and author articles Qualifications:  •  Minimum eight years of recent estate, gift, and trust tax experience with a law firm, an accounting firm, the IRS/Treasury, and/or a bank or corporation...
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Springer Nature-Jersey City
is limited to revised editions). From timely and accurate contract processing to calculations, statements, payments, and author query resolution, being part of the global Book Royalty department. Managing royalties for book series globally and working closely...
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