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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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In this role, the Research Scientist will author and/or review assay development plans, project reports, procedures, and other assay-related documentation and independently execute experiments according to project plans.
$83,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Author and execute design, commissioning, qualification, and validation documentation and support records to certify compliance with specifications and procedures. Strong technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT – write and execute test scripts, author test summary reports.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Author CMC sections for filing and maintenance of INDs, CTAs, IMPDs, NDAs and MAA submissions as well as CMC source documentation for our clinical programs. Adhere to generally accepted writing standards to support CMC documentation.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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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.
Part-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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As the Technical Author on the team, you will collaborate with software developers, product managers, community members, other documentation authors, information architects, quality assurance engineers and technical support engineers to develop clear documentation for complex technical topics.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Author detailed product requirements documentation to ensure alignment across functions and increase velocity of throughput. This position will be directly supporting the ViewPoint Site CTMS (Clinical Trial Management System), a software platform that serves as the day to day workflow tool for clinical research coordinators, provides a digital trial protocoland includes modules to track nearly every aspect of a clinical trial, from budgeting to site management to point-of-care communication.
$217,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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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 20 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.
Full-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Author and update internal and external documentation, and formally initiate and deliver business requirements and documentation. Partner with stakeholders across business units (ex: portfolio managers, quants, marketing, operations, risk, compliance) to develop analyses and documentation in a collaborative way.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Regulatory data creation to author documentation supporting filings and responses to health authorities globally. Lead and develop a drug substance team for preclinical through commercialization to support biologics program advancement.
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author documentation jobs in Brookline, MA
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