Author Jobs in Waltham (MA)
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Search Results - Author Jobs in Waltham (MA)
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 -
Apellis Pharmaceuticals, Inc.-Waltham (MA)
author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings.
Work...
jobvertise.com -
AbbVie-Boston, 10 mi from Waltham (MA)
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...
resume-library.com -
Vertex Pharmaceuticals Inc (US)-Boston, 10 mi from Waltham (MA)
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...
appcast.io -
Katalyst Healthcares & Life Sciences-Cambridge, 6 mi from Waltham (MA)
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...
resume-library.com -
GForce Life Sciences-Newton (MA), 4 mi from Waltham (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...
mindmatch.ai -
BioPharma Consulting JAD Group-Boston, 10 mi from Waltham (MA)
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...
resume-library.com -
Ocular Therapeutix, Inc.-Bedford (MA), 6 mi from Waltham (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...
mindmatch.ai -
Initial Therapeutics, Inc.-Boston, 10 mi from Waltham (MA)
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...
appcast.io -
Aditi Consulting-Lexington (MA), 5 mi from Waltham (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:...
jobg8.com -
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