Author Jobs in Cambridge
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Search Results - Author Jobs in Cambridge
Eurofins USA PSS Insourcing Solutions-Cambridge
resource for potency assays.
Execution of complex GMP release and stability assays such as cell based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
Author and review SOPs and technical reports.
Work with cross-functional groups...
resume-library.com -
Symbotic-Cambridge
technicians and contractors conducting hands-on mobile robot testing.
• Validate the test fixtures, stimulus, and automated software to meet test requirements across multiple manufacturing locations.
• Author comprehensive repair test specifications...
Eurofins USA PSS Insourcing Solutions-Cambridge
of analytical methods
Analyze data; interpretation of data within given parameters
Write QEs and Investigate out of specification or unexpected results and study outcomes
Escalate and assist in the resolution of complex issues
Independently develop, author...
resume-library.com -
Cambridge
of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate...
pharmiweb.jobs -
Lifelancer-Cambridge
and approach for safety evaluations
Analyze safety data and author safety assessment
Collaborate with PSLs, scientists, pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety...
resume-library.com -
Randstad-Cambridge
and regulatory submissions
• Author and review technical reports and sections of regulatory filings.
• Support process and method lifecycle management, including testing to support method remediation, qualification and transfer as well as process improvements...
randstadusa.com -
Katalyst Healthcares & Life Sciences-Cambridge
and review implementation plans to ensure up-to-date, compliant information is provided.
Labelling Document Management.
Author and manage the creation of new/revised labeling documents (TLP, CCDS, USPI, EU SmPC) with input from relevant functional areas...
resume-library.com -
Cambridge
community.
Responsibilities:
Event Creation, Development, and Execution:
• Conceptualize, plan, and execute trade book events such as author signings, book launches, panel discussions, and community gatherings.
• Coordinate with authors, publishers...
icims.com -
LanceSoft Inc-Cambridge
activities and owning and authoring deviation investigation reports for the FEV (Facilities, Engineering and Validation) department, as well as revising and writing procedures, and acting as document coordinator .
Primary Responsibilities:
Update, author...
resume-library.com -
Foghorn Therapeutics-Cambridge
strategy, and clinical trial design
• Author and review preclinical study reports, including nonclinical toxicology, DMPK and biomarker sections of regulatory documents
• Design and interpret PK/PD, efficacy and toxicology studies in collaboration...
workable.com -
eTeam Inc.-Cambridge
and authoring deviation investigation reports for the FEV (Facilities, Engineering and Validation) department, as well as revising and writing procedures, and acting as document coordinator.
Primary Responsibilities:
• Update, author and review FEV standard...
resume-library.com -
Editas Medicine-Cambridge
development of HSC-based therapies from early discovery to regulatory filing.
• Establish SOPs, write prospective protocols, author study reports and regulatory documents, assist patent filing, and contribute to business development activities.
• Maintain...
workable.com -
AbbVie-Cambridge
risks and provide recommendations for partnership or in-licensing.
Author and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs, regulatory queries) and interact with regulatory agencies (US and ex-US) as needed.
Generate impurity, excipient...
resume-library.com -
AbbVie-Cambridge
as their role in achieving those objectives.
Make significant contributions to project teams through lab-based, or other work environment activities.
Analyze and interpret experimental data using statistical methods, author protocols and scientific reports...
resume-library.com -
Aditi Consulting-Cambridge
B.S. and about 4 YOE is ideal. Based small molecule lab skills and wet lab experience.
Top 3 Must Have Skill Sets:
Generate, analyze, and critically evaluate analytical data to support investigations and regulatory submissions
Author and review...
resume-library.com -
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