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Author Jobs in Waltham (MA)

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Search Results - Author Jobs in Waltham (MA)
Deciphera Pharmaceuticals-Waltham (MA)
lead in regulatory submissions and inspections Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles Author/review statistical...
resume-library.com -
CSL Seqirus-Waltham (MA)
and Posters; facilitate Team calls to review upcoming publications planned, progress of manuscripts and congress abstracts and posters planned.  •  Provide direction to authors to ensure timely manuscript submission for RD disclosure approval including...
Deciphera Pharmaceuticals-Waltham (MA)
oversee CDMO development and qualification activities required to support and launch activities as well as advise on additional early phase program development. Support writing and review applicable sections of CMC regulatory filings. Author and review...
resume-library.com -
Evolv Technologies Holdings, Inc.-Waltham (MA)
to customers.  •  Author at least one Product Requirement Document (PRD), showcasing your ability to detail requirements that reflect an understanding of market/customer needs with articulated outcomes.  •  Build relationships with and establish close and frequent...
workable.com -
Deciphera Pharmaceuticals-Waltham (MA)
test data for IPC testing, drug substance/product batch release and stability test data. Author and/or review standard operating procedures (SOPs) relating to quality control. Manage stability activities at CDMOs and compile/analyze stability data...
resume-library.com -
Editas Medicine-Waltham (MA)
commissioning & qualifications.  •  Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.  •  Author, review and/or approve GMP documentation (SOPs, batch records...
workable.com -
Evolv Technologies Holdings, Inc.-Waltham (MA)
Author at least one Product Requirement Document (PRD), showcasing your ability to detail requirements that reflect an understanding of market/customer needs with articulated outcomes. Build relationships with and establish close and frequent...
resume-library.com -
Takeda Pharmaceutical-Boston, 10 mi from Waltham (MA)
Investigate and document findings and influence assessment for deviations mostly minor, some major Provide subject matter expertise on manufacturing process to support deviations owned by other departments Author calibration Out of Tolerance (OOT) impact...
Editas Medicine-Waltham (MA)
commissioning & qualifications. Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations. Author, review and/or approve GMP documentation (SOPs, batch records...
resume-library.com -
Takeda Pharmaceutical-Lexington (MA), 5 mi from Waltham (MA)
and selection of new equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Perform functional equivalency. Author and review sections of regulatory filings and annual product quality reviews. Important Considerations At Takeda, our...

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