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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer). Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
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Partner with IT and QA on the change management, release management, and ongoing validation of all Regulatory Operation computer systems. Support Acadia's regulatory systems portfolio including Veeva Vault Submissions, IQVIA RIM Smart, and other utilities and tools used in the management of regulatory information and submission production, partnering with IT, and vendors.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Applies specialized Epic Tapestry knowledge to improve processes and support strategies, assists junior personnel, and is responsible for ongoing assessment, design, validation, development, and implementation of the Epic system.
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Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues.
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Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
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The Sarbanes-Oxley (SOX) Control and Compliance Manager will lead the Company’s internal controls program, perform regulatory compliance audits as needed, and support the Company’s Environmental, Social and Governance (ESG) and Enterprise Risk Management (ERM) programs.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus. Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
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Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met. Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirementsReview and approval of equipment specification/design/procurement/installation and validation.
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We are hiring for a Staff Engineer to join our Van Note-Harvey business and contribute to our water resources & municipal projects on a full-time, direct basis at our office in Princeton, NJ. Primary Responsibilities: Contribute to water and wastewater infrastructure planning projects: design, permitting, inspection & construction administration (including pump stations, distribution, collection & conveyance, storage tanks, and treatment.
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Civil Engineer Location: Princeton, NJ Salary: $95,000 - $110,000 DOE Responsibilities: Civil Design: Lead and manage the design of roadways, intersections, ADA curb ramps, parking facilities, and pedestrian infrastructure.
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Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer). Experience in Process qualification, validation.
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Who we are looking forState Street Global Technology Services ERM systems is looking for an experienced Application Architect/Sr. Software Engineering Manager to manage Enterprise Risk Management Applications.
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Ranked the overall #4 Best Civil Engineering Firm to Work for in the Nation (#1 in our size category) and residing on the list of the Engineering News Record (ENR)’s Top 500 Design Firms in the nation, TPD (Traffic Planning and Design, Inc.) is currently hiring a Civil Engineer for design projects in New Jersey and Pennsylvania.
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validation engineer regulatory jobs in Princeton, NJ
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