Medical Writer

Job Summary

A company is looking for a Medical Writer to develop high-quality clinical and regulatory documents.

Key Responsibilities

• Prepare and author clinical and regulatory documents, including protocols, reports, and applications
• Collaborate with cross-functional teams to ensure alignment of documents with study objectives and regulatory requirements
• Ensure compliance with regulatory guidelines and maintain up-to-date knowledge of writing best practices

Required Qualifications

• Minimum 3-5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry
• Strong background in writing regulatory documents for clinical trials and submissions
• Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field
• Proficiency in ICH guidelines, GCP, and regulatory submission requirements
• Experience with document management systems and publishing tools