FSP Senior Scientist-Scientific Writer
Core
Author validation and sample analysis reports for PK, Immunogenicity, and biomarker endpoints; manage regulatory document lifecycles in Veeva systems.
Role type
Senior Scientific Writer (Bioanalytical Reporting)
Builds
Bioanalytical reports (PK, Immunogenicity, Biomarkers) and regulatory study documentation
Domain
Clinical Research / Bioanalytical Services / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical Writing, Bioanalytical Reporting, GCP Compliance, Regulatory Document Management, Veeva Vault, Quickbase, Microsoft Office, Adobe
Preferred skills
Pharmacokinetic (PK) studies, Immunogenicity studies, CRO environment experience
Technologies
Veeva Vault, Quickbase, Microsoft Office, Adobe
Responsibilities
Author validation and sample analysis reports for PK, Immunogenicity, and biomarker endpoints; QC and address comments from document review meetings; Retrieve and upload finalized bioanalytical CRO reports to Veeva regulatory vault; Cross-link finalized reports to Veeva study TMF; Update Quickbase report listings; Conduct TMF completeness checks; Provide study-related document listings for m271 and integrated summaries.
Seniority
Senior, hands-on IC
