Technical Writer III - Lab Operations
Core
Create validation protocols, reports, and specifications for analytical methods in a pharmaceutical development laboratory.
Role type
Technical Writer III / Validation Specialist
Builds
Analytical method validation protocols, transfer protocols, reports, and specifications
Domain
Pharmaceutical / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation, GMP/GLP compliance, ICH/FDA/USP/NF/Ph. Eur. regulatory knowledge, technical document preparation, risk assessment writing
Preferred skills
Training scientific writers, client meeting participation, compendial update assessment
Technologies
Chemstation, OpenLab, Microsoft Office Suite
Responsibilities
Prepare method validation and transfer protocols and reports; perform analytical assessments of compendial updates; generate method transfer plans; attend client meetings regarding technical document requirements; write advanced reports like Elemental Impurity Risk Assessments; provide training to other Scientific Writers
Seniority
Mid-level, hands-on IC
