Senior Medical Writer

A company is looking for a Medical Writer - Real World Evidence (RWE), Regulatory and Life Sciences Research.

Key Responsibilities

Author and QC regulatory-grade RWE documents, including study protocols, statistical analysis plans, and regulatory submission documents

Interpret complex observational and claims data in collaboration with biostatisticians and programmers

Ensure scientific accuracy, compliance with regulatory standards, and support submission readiness

Required Qualifications

MS or Doctoral degree in epidemiology, biostatistics, or public health

At least 7 years of medical writing experience, with 5 years in real-world data / evidence

Deep understanding of RWE methodologies and regulatory expectations

Proficient in tools such as EndNote and Veeva Vault / RIMs

High level of collaboration and self-motivation for remote work