Associate Director, Medical Writing

Candidates must possess a minimum of a Bachelor's degree in Life Sciences or a related discipline, with an advanced degree being preferred. A solid understanding of biochemistry and molecular biology principles is required, along with a minimum of 5 years of experience writing clinical and regulatory documents for a pharmaceutical or biotechnology company. Proficiency in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per guidelines is essential. Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes is necessary. Candidates should be proficient with Microsoft Office, Adobe Acrobat, and shared document systems like SharePoint and Veeva. The ability to work independently, prioritize tasks, problem-solve, complete high-quality documents under aggressive timelines, and a commitment to accuracy and detail are also required.