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Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to Health Authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
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Ensure data integrity by timely completion of phase-appropriate documentation, including experiment recording in electronic notebook system, develop protocols, and author reports to support future technology transfer and regulatory filings.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Author, review, and/or approve Policies, Standard Operating Procedures (SOPs) Work Instructions (Wis), and supporting documentation related to GMP activities. Continuously improve and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards.
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Author regulatory submission documentation, including SRDs, IDEs, and PMAs. Ensure that software and data products are developed and validated to standards required for FDregulated products and/or for data included as part of a drug or diagnostic regulatory submission (e.g. SRDs, IDEs, Pre-Submissions, PMA.
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Collaborate with the IT Operations, Service Desk, IAM, Information Security, and other team members in the documentation and implementation of processes and procedures for software and hardware asset management for the enterprise system environments.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Author detailed product requirements documentation to ensure alignment across functions and increase velocity of throughput. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.
$184,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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A Technical Author leads the documentation efforts of an engineering team, typically focused on a product or family of products. Has a record of community engagement, in open-source software, documentation, research or other disciplines.
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Execute the SDLC Activities and develop\author key validation and System Lifecycle documents: Validation Plans and Summary Reports, Specifications (URS, FRS, CS), Testing Documentation (Plans, Test Protocols, Test Cases & Scripts), Trace Matrix etc.
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Author and maintain detailed validation documentation, including protocols, reports, and deviations. Proven experience with commissioning and qualification of equipment such as bioreactors, chromatography systems, and HVAC systems.
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Author and develop SOP and VMP for computer system validation for manufacturing equipment. Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
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Review, interpret results, and author translational medicine and clinical pharmacology-related clinical documentation, including clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology components of investigator brochures, regulatory documents.
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Strong communication skills, including ability to author technical documentation and deliver presentations on technical topics. Design, create, and validate software which combines computer vision, ML, functional safety, and embedded systems.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Author and maintain documentation as required to sustain regulatory compliance. College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
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Driving adherence to global regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals.
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