Author Jobs in Massachusetts
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Search Results - Author Jobs in Massachusetts
AbbVie-Boston
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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1 similar job: North Chicago
Vertex Pharmaceuticals Inc (US)-Boston
as the functional representative.
3. Works under supervision to author study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells, and presentation to Statistical Review Forum (SRF).
4. Plans and conducts Cross-functional Data Review...
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Katalyst Healthcares & Life Sciences-Cambridge
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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Ocular Therapeutix, Inc.-Bedford (MA)
laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, Dissolution etc).
• Author technical reports as required.
• Ensure instrument calibration and qualification is up to date and performed on a scheduled basis.
• Troubleshoot any issues...
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BioPharma Consulting JAD Group-Boston
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...
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RoslinCT-Hopkinton (MA)
enrollment, implementation and activation.
• Assist with assessments of GXP applicability and GAMP categorization for new equipment based on intended use.
• Author user requirement specifications for equipment/systems.
• Support risk assessments for equipment...
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Aditi Consulting-Lexington (MA)
Payrate: $ - $ Team overview:
• A typical day involves working through a QC checklist, identifying potential issues, and working with the document authors and scientific staff to resolve conflicts.
Role description:...
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Initial Therapeutics, Inc.-Boston
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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GForce Life Sciences-Newton (MA)
engineering disciplines
• Author relevant documents related to process improvements
• Develop test methods, protocols, execute tests, prepare reports and release them via ECOs
• Support system builds, inventory management, and procurement activities
• Lead...
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Initial Therapeutics, Inc.-Boston
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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AbbVie-Worcester
and quality of technical reports
Provide project update, analysis and advice to cross-functional teams and senior management
Present original work internally across departments and at internal and external scientific conferences; may author or co-author peer...
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Barrington James-Boston
and nurture relationships with customers engaged in quantum research and development, including projects focused on scaling, error correction, and early-stage experimentation.
• Co-author white papers and scientific publications in collaboration...
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AbbVie-Boston
development
Responsibilities:
Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation.
Partner with subject matter experts in various process development functions to ensure technical information...
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Mantell Associates-Boston
data to produce strategically relevant abstracts, presentations and manuscripts
• Author (and/or work with medical writer to develop) other clinical documents like, briefing documents and other regulatory filings, IND annual reports, Investigators...
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Dyne Tx-Waltham (MA)
to support clinical pharmacology and related activities.
• Author high-quality regulatory documents.
• Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and drug development...
appcast.io -
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