Medical Writer

The Role: As a Medical Writer, you will be working on medical writing within the clinical research/pharmaceutical industry, with a strong focus on Phase 1 and Phase 2 clinical trials. This role requires a deep understanding of ICH GCP guidelines, regulatory requirements, and compliance standards set by relevant agencies (e.g., FDA, EMA). In this role you will play a critical role in developing high-quality, scientifically accurate, and regulatory-compliant clinical trial documents that support the development of innovative therapies.

Key skills/knowledge/experience:

1. Professional experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.
2. Strong understanding of clinical research methodologies and regulatory requirements (In-depth knowledge of ICH GCP guidelines, and compliance standards (e.g., FDA, EMA)).
3. Ability to work independently and as part of a team.
4. Proven track record of authoring and managing regulatory documents such as study protocols, IBs, and CSRs.