Medical Writing Coordinator

A company is looking for a Medical Writing Coordinator / Publisher II (Remote) to manage clinical and regulatory documentation.

Key Responsibilities

Format, publish, and coordinate Clinical Study Reports (CSR) Appendices and ensure compliance with regulatory standards

Maintain knowledge of regulatory information management systems (RIMS) and assist in the development of medical writing operations processes

Mentor and provide guidance to less experienced staff while tracking metrics and managing communication with stakeholders

Required Qualifications

A minimum of 4 years of relevant industry experience in medical writing within pharma, biotech, or life sciences

High School diploma required

Knowledge of clinical document organization, eCTD structure, and drug development processes

Detail-oriented with a commitment to delivering high-quality and compliant documentation

Ability to work independently and collaboratively in a team environment