Technical WriterApply Now
Location: Waltham, Massachusetts 02451
Employment Type: Contract
Job Description
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
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