Senior Medical Writer

A company is looking for a Senior Medical Writer responsible for developing clinical regulatory documents related to an investigational psilocybin therapy.

Key Responsibilities

Leads preparation of clinical regulatory documents, including CSRs, protocols, and clinical summaries

Ensures clarity and accuracy of clinical documents in accordance with regulatory standards

Oversees outsourced medical writing services and provides subject matter expertise to the regulatory sciences team

Required Qualifications

Bachelor's degree in life or health sciences; MSc or PhD preferred

Considerable experience in regulatory medical writing within the pharmaceutical or medical industry

Experience in leading the development of clinical documents as part of a multi-functional team

Broad knowledge of the clinical drug development process and relevant ICH guidance

Alignment to company culture and values