Senior Manager, Medical Writing

Role: Senior Manager in Global Regulatory Medical Writing responsible for preparing and editing complex clinical regulatory documents for drug submissions, including study reports, protocols, and investigator’s brochures. The position involves providing oversight, guidance, and resource management for medical writing activities at a project level. Responsibilities include ensuring document accuracy, regulatory compliance, and clear scientific messaging, as well as supporting process improvements and mentoring other writers. Qualifications: Bachelor's degree in life sciences or related field; 8+ years of relevant experience in clinical regulatory writing, with mastery of Microsoft Word and familiarity with electronic systems like Veeva Vault. Preferred: advanced degrees (Master’s, PhD, MD, PharmD). High-Value: experience with global regulatory guidelines, multiple therapeutic areas, and complex documentation standards. Industry-specific knowledge includes familiarity with drug development stages and regulatory submission requirements. Collaborates with cross-functional teams to deliver high-quality documentation aligned with regulatory timelines. Work setup is not explicitly specified. Travel requirements are not mentioned.