Medical Writer I

Job Summary

We are looking for a Medical Writer I to support the preparation review and delivery of clinical and regulatory documents. The ideal candidate will have a strong scientific background excellent writing skills and an understanding of clinical research and drug development processes.

Key Responsibilities

• Author edit and review clinical and regulatory documents including: Clinical Study Reports (CSRs) Interim Study Reports Informed Consent Forms (ICFs) Safety Update Reports Patient Narratives

• Conduct literature searches and scientific reviews to support document development.

• Analyze and interpret clinical study data to prepare high-quality scientific content.

• Ensure compliance with ICH-GCP guidelines SOPs templates and regulatory requirements.

• Perform quality checks to ensure data accuracy consistency and document integrity.

• Collaborate with cross-functional teams including Clinical Operations Biostatistics Data Management Regulatory Affairs and Medical Affairs.

• Support document review cycles manage timelines and address stakeholder feedback.

Skills

• Strong clinical and scientific writing skills.

• Good understanding of clinical research drug development and regulatory guidelines.

• Experience with medical writing clinical documentation or medical communications.

• Excellent written and verbal communication skills.

• Strong attention to detail and organizational skills.

• Proficiency in Microsoft Word Excel SharePoint and document management systems.

• Ability to manage multiple projects and work effectively in a collaborative environment.

Qualifications

• Bachelors or Masters degree in Life Sciences Pharmacy Biotechnology Medicine or related healthcare discipline.

• Experience within a CRO pharmaceutical biotechnology healthcare or medical communications organization preferred.