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
Medical Writer • Macon, Georgia, United States