Author Jobs in North Reading
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Search Results - Author Jobs in North Reading
AbbVie-Boston, 15 mi from North Reading
Job Description
The Director II NBE Author leads the development and oversight of Chemistry, Manufacturing, and Controls (CMC) dossier strategy and authoring to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications...
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Initial Therapeutics, Inc.-Boston, 15 mi from North Reading
human PK/PD data to inform dose escalation and dose regimen selection for proof-of-concept studies.
• Author, review and approve key documents, including protocols, risk profiles, informed consent documents, clinical study reports, and disclosure...
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Katalyst Healthcares & Life Sciences-Cambridge, 14 mi from North Reading
Responsibilities:
Author and review of GxP documents (e.g.- SOPs, Protocols, Technical Reports, Trend reports etc. related to QC microbiological and Environmental Monitoring activities).
Support site qualification/validation/commissioning...
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EPM Scientific - Phaidon International-Boston, 15 mi from North Reading
for biologic products.
• Manage stability programs and oversee stability studies at Contract Development and Manufacturing Organizations (CDMOs).
• Author and review technical reports, protocols, and regulatory submissions, including IND, IMPD, BLA, and MAA...
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Azzur Group-Burlington (MA), 8 mi from North Reading
air, nitrogen, and process gases.
Review and redline utility P&IDs, execute system walkdowns, and ensure system readiness for validation.
Author and review utility-related documents, including User Requirement Specifications (URS), Functional...
resume-library.com -
Initial Therapeutics, Inc.-Boston, 15 mi from North Reading
Responsibilities
• Lead all PK- and ADME-related efforts for designated program(s).
• Communicate and present relevant information across all areas of the organization, regardless of level.
• Select and manage PK/TK, PK/PD, and ADME CROs.
• Author and review PK/TK...
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Fidelity Investments-Boston, 15 mi from North Reading
and author conceptual, logical, and physical data models
• Create project documentation including current/future state diagrams, process flows, business requirements, test cases and issue tracking
• Support organizational testing, readiness, and deployment...
Fidelity Investments-Boston, 15 mi from North Reading
Support and author conceptual, logical, and physical data models
• Create project documentation including current/future state diagrams, process flows, business requirements, test cases and issue tracking
• Support organizational testing, readiness...
Leidos-Tewksbury (MA), 8 mi from North Reading
completed for each platform product
• Author and review IS security-related documentation and submit to Enterprise Mission Assurance Support Service (eMASS)
• Analyzing results of continuous security scans (from Fortify, SonarQube, ACAS, OWASP, etc) to add...
Katalyst Healthcares & Life Sciences-Lexington (MA), 11 mi from North Reading
spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc).
Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems.
Author validation life cycle documents for client's review...
resume-library.com -
Leidos-Boston, 15 mi from North Reading
/subsystem requirements
• Perform functional analysis, requirements allocation and analyses of alternatives
• Support system hardware-software-network design, development, integration, site installation, testing and verification
• Author and review...
Katalyst Healthcares & Life Sciences-Andover (MA), 6 mi from North Reading
presentations.
Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust...
resume-library.com -
BioPharma Consulting JAD Group-Boston, 15 mi from North Reading
control
• Participate in internal and external meeting
• Author and/or review technical documents, including method SOP, study protocol and technical report
• Author and/or review regulatory filing/response
Knowledge and Skills:
• Hands-on experience...
workable.com -
Capital One-Cambridge, 14 mi from North Reading
by accomplishments such as first author publications or projects.
• Possess the ability to own and pursue a research agenda, including choosing impactful research problems and autonomously carrying out long-running projects.
Basic Qualifications:
• Currently has...
Capital One-Cambridge, 14 mi from North Reading
to existing products.
• A professional with a track record of coming up with new ideas or improving upon existing ideas in machine learning, demonstrated by accomplishments such as first author publications or projects.
• Possess the ability to own...
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