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Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare regulatory submission documentation. Author DMPK, nonclinical toxicology, and biomarker sections of regulatory documents.
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The ideal candidate for this role will author/review documentation for late-stage process development activities and work cross-collaboratively to identify gaps and add manufacturing robustness for the preparation of engineering lots through validation and PPQ.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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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 1 month ago - UpvoteDownvoteShare Job
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An agile development practitioner with strong experience using tools such as Jira and Confluence to create user stories and author product documentation. Play a critical role in communication via multiple artifacts, business leader communication, author feature briefs and detailed release notes.
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Support enhancements to the Veeva quality management system (QMS) vendor management and audit modules, author procedures, perform training. Upload Quality Agreements and other documentation into Veeva.
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Support the GLP/GMP vendor management program, including maintaining the Approved Supplier List, performing vendor risk assessments, audit planning, scheduling, pre-audit meeting scheduling, and observation follow-up.
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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, review and/or approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing and QC testing.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Principal Product Manager will play a critical role on our Product team leading a team through critical state legislated product changes and claim efficiency capabilities. Principal Product Manager page is loaded.
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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.
$152,000 - $217,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Author and update user need and design requirement documentation using best Systems Engineering principles. Author and execute protocols and technical reports summarizing key findings and results.
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Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Data analysis (software: e.g. JMP, Minitab) Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization or qualification in a GMP environment.
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Author audit reports and coordinate supporting documentation; manage same in QMS. Author audit reports and coordinate supporting documentation; manage same in QMS. Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
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Author, review, and revise standard operating procedures (SOPs) and ensure all quality documentation complies with GMP, regulatory requirements, and corporate standards. Support quality assurance operations by reviewing production records, testing documentation, and overseeing lot disposition activities to ensure compliance with quality agreements and GMP standards.
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Drafting the proposal and supporting the proposal’s co-author(s) in content, style and structure. The Tender Manager will be responsible for all execution and managerial aspects of the tendering process and provision of best-in-class documentation for submissions.
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author documentation jobs in Watertown, MA
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