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Author and review stability protocols related to the company’s AAV gene therapy and RNA PMO product pipelines. Author and review stability protocols related to the company’s AAV gene therapy and RNA PMO product pipelines.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The job purpose and scope of the Clinical Research Scientist is to author the scientific documents associated with design, conduct, and reporting of clinical trials in the therapeutic area of Heart Failure, particularly mechanical circulatory support and hemodynamic monitoring.
$145,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ability to author site work plans, reports, and proposals for complex scopes of work. Remediation Expertise: Evaluate subsurface characteristics for soil, soil vapor, and groundwater remediation projects, and apply remedial systems and solutions.
$90,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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In addition, advice and author the new Integrated Program Management Report (IPMR) CDRLs for new contract efforts to establish tailored submission formats and establish variance threshold instructions for Formats 5 and 6 of the new CDRL.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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As a Quality Assurance Specialist, you will engage in batch record review, assist in writing SOPs, and author Annual Product Review Reports. As a Quality Assurance Specialist, you will engage in batch record review, assist in writing SOPs, and author Annual Product Review Reports.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Author post-market surveillance reports. Author and support regulatory filings for market clearance, licensing, registration, and legalization. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Author high quality and timely investigations within the Pfizer quality systems (i.e. eQMS) Author PQS compliance assessments. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
$107,600 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Monitors EVM and FM existing Contract Data Requirements List (CDRL) for compliance and completeness. Serves as the liaison for all EVM matters between the Government and the Prime Contractor, through coordination and regularly scheduled meetings with the Prime Contractor Program Control Offices.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Revise and author standard operating procedures/batch records/work instructions to optimize usability and compliance. Point of contact for new manufacturing employee onboarding and Act as a resource/SME.
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The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory’s Quality Management System for domestic and various international markets for SaMD products.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Contribute to or author proposals and can participate on business capture efforts. RF Engineer Hourly: $70 - $88/hour Location: Chelmsford, MA (fully on-site) Shift: 4/10, 1st shift (6am - 4:30pm) Industry: Government/Defense Employment Type: Long-term contract with potential for permanent employment Clearance: Active Secret Qualifications: BS degree in electrical engineering or closely related technical field.
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Author audit reports and coordinate supporting documentation; manage same in QMS. Bachelor’s degree in a scientific discipline with 10+ years’ experience in the pharmaceutical or biotech industry and GCP Clinical Quality Assurance.
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Contribute to sections of reports and proposals and author speeches, presentations, technical articles, and correspondence with limited need for revision, reorganization, or editing during the peer/senior review process.
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Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs Author/revise standard operating procedures (SOPs) and test methods, as required Other duties as assigned Work Conditions: Office Physical Requirements: Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance Talk or hear Close vision Computer/office machines Lift up to 10 lbs.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Author and maintain standard operating procedures (SOPs) and train key personnel as needed. Author and maintain standard operating procedures (SOPs) and train key personnel as needed. The Senior Regulatory Affairs Program Lead is responsible for managing the collaboration with cross-functional stakeholders to ensure regulatory compliance is met.
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author job in North Billerica, MA
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