Senior medical writer - (Princeton, NJ)

Sr. Medical Writer Theradex is recruiting for a highly collaborative Senior Medical Writer to join our team either remote or based in Princeton, NJ. We are seeking a motivated individual with science, research and/or clinical experience who would like the opportunity to be involved in the development of many new products being evaluated for the treatment of cancer. What you'll do: *Prepare documents for regulatory submissions, including (but not limited to) Initial Investigational New Drug (IND) applications and amendments, clinical study reports, annual reports, clinical study protocols/amendments, informed consents, investigator brochures, briefing/meeting packages *Handle regulatory submission qualifications and processes *Assist with responses to questions from regulatory agencies *Provide writing/editing services and QC to other in-house units *Serve as a resource for new medical writers *Lead cross functional project teams and act as a project leader with manager oversight What you need: *Min of a BA/BS