Scientific Writer (2008018)

DescriptionThis individual will be responsible for working closely with Research members to develop manuscripts and technical documents, review articles for peer-reviewed journals, and quality checks of documents written by department members. Other responsibilities may include providing assistance with formatting, writing, editing, and coordination of complex integrated non-clinical research documents including INDs, BLAs, responses to questions from regulatory agencies and technical documents for CMC & Manufacturing.Required Skills



The individual must:Have excellent communication & interpersonal skills and be self-motivatedBe detail orientedHave ability to write a wide variety of different kinds of pieces under very tight deadlinesCollaborate with team members from a variety of specialties. Required Experience



Job requirements are as follows:Proven experience in biotech/pharmaceutical industry, with at least 4 years experience as a scientific writer.Candidate must have an understanding of research activities, including cell biology, pharmacology, and toxicology.Strong understanding of drug development and background in biologics is desirable.Experience preparing INDs, NDAs, and/or BLAs is desirable. Knowledge of FDA regulatory guidelines is also preferred.Incumbent must have strong written and verbal communication skills and the ability to work independently.Candidate must be able to work in a cross-functional team environment, with the ability to progress multiple projects simultaneously.