Medical Writer

Summary

The job is a 12-month remote contract position for a primary author of complex regulatory/clinical documentation with a biopharmaceutical client. The employee will work on IND's, BLA's, CSR's, Protocols & IB's and collaborate cross-functionally with Safety & Regulatory.

Requirements

• Degree in Life Sciences
• 5 years experience as a primary author of documents such as IND's, CSR's & Protocols

Responsibilities

• Serve as primary author for complex regulatory/clinical documentation
• Author/Co-authoring of IND's, BLA's, CSR's, Protocols & IB's
• Writing, reviewing & editing of scientific early-phase clinical documentation

Preferred Qualifications

• Oncology experience
• Prior experience working with milestones & timelines