Job Title : Process Development Technical Writer

Location : Waltham, Massachusetts (Remote)

Duration : 9+ Months (Extendable Contract)

Responsibilities

•Prepare late-stage development reports in support of Alkermes 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

Education and Experience 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

Knowledge/Skills:

•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

•Familiarity with conventions in form, structure, and notation of technical writing

Additional Desired Knowledge/Skills:

•Experience publishing in scientific journals

•Experience with interpretation of scientific data