Technical Writer

Contract Length: 9 months

 

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:

• Bachelor’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