Our client is looking for a Senior Medical Writer with 10+ years of experience a majority falling within the therapeutic area of Oncology. They will need this professional to have regulatory writing experience, such as but are not limited to: CSRs, briefing books, IBs, regulatory responses, IND/NDAs, annual updates to regulatory submissions. Essentially the client will need someone to look through their documents and revise and can come and clean them up. The specific submission to the FDA will be for an Oncology oriented imaging device. The Client does not have any writing templates so it is expected that the Senior Medical Writer has experience building templates from scratch.
Developing of imaging device with FDA (+)
Device development experience is a (+)
Remote: Senior Medical Writer (232439)