Experienced technical writer to support a large pharmaceutical nitrosamine risk-assessment programme. Support role, enabling scientific subject-matter experts to focus on technical decisions while this role manages the technical writing & documentation workload across a portfolio of ~20 product families
Author and revise the core documentation set: Internal (INH) NRER, Regulatory NRER, and Risk Summary Reports, including revisions after Confirmatory Testing outcomes.
Draft CT protocols and reports; support report writing and TV approval routing[
Support cross-contamination assessments and quality-record documentation (NC/CC/CAPA as applicable).
Work closely with cross-functional teams—including Analytical Development, Toxicology, Process Chemistry, MSAT, Quality Assurance, and Regulatory Affairs—to draft, review, and manage scientific justification reports
Proven scientific / technical writing experience in a GMP pharmaceutical environment.
Familiarity with CMC documentation and electronic quality management systems.
Ability to work across multiple product teams simultaneously and manage competing deadlines.
Strong foundational understanding of drug development, pharmaceutical manufacturing processes, and trace-level impurity evaluations (specifically nitrosamines/NDSRIs)
N/A
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