CMC Regulatory Submissions Writer Remote, Remote
Job Ref: JOB-46642
Writing Assistance, Inc. is a national staffing company for Medical Writers.
Our client is in the biotech industry creating vaccines. They are looking for a Technical Writer who can help draft and review technical reports and the regulatory sections working with the Technical SME in the Analytical Development team, Process team, and Production team.
They are looking for a writer with a CMC background and who can work through challenges in phase 1, 2,3 and life cycle management projects. This work is for completing Dev Reports for regulatory submissions. The primary scope of work revolves around assay development, setting specifications, release and stability data, process (cell line, upstream, downstream) and formulation, fill finish operations. Most of the work can be completed using MS Office.
They would prefer a writer who can be onsite as needed in San Diego, CA, but open to 100% remote.