Technical Writer
JVT AdvisorsWaltham, MA, US30+ days ago
Job descriptionBachelor’s degree in science or related discipline 5+ years prior experience in the pharmaceutical industry with a focus on biologics product development and manufacturing in mammalian systems Excellent written and verbal communication skills Prior experience writing technical reports in the biological sciences Excellent collaboration skills with focus on timely delivery Ability to handle multiple tasks independently and manage competing priorities High technical understanding of biologics development, including analytical test methods Advanced skills using MS Word, specifically document and table formatting Knowledge with the interpretation and application of guidance’s including ICH, USP / NF, EP
Job Summary :
This individual will be responsible for writing Technical Reports, Summary Reports, and other documentation in support of a novel active pharmaceutical ingredient (API) being developed within the immuno-oncology biologics pipeline.
Responsibilities :
- Prepare late-stage development reports in support of the company’s pipeline biologics development program
- Collaborate with Process Development, Analytical Development, Formulation Development, Technical Operations, Quality and Regulatory functions in preparing and reviewing development reports
- Critically review documents for consistency and quality
Requirements :