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

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare discipline.

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