Medical Writing Manager (Hybrid)

Role: Medical Writing Science Manager responsible for preparing and reviewing moderately complex clinical and regulatory documents in biopharma, contributing scientific expertise to clinical development. Responsibilities: authoring clinical study protocols, reports, investigator’s brochures, and regulatory submission sections; serving as lead Medical Writing Scientist for study teams; supporting data analysis and interpretation; ensuring scientific consistency across documents; contributing to product development plans and process improvements. Requirements: Ph.D. degree; approximately 4+ years of experience in clinical regulatory writing; strong communication skills; broad understanding of drug development, study design, biostatistics, regulatory requirements, and medical terminology; proficient in document management tools. Preferred skills: experience with clinical study data interpretation and cross-functional collaboration. HighValue: focus on clinical regulatory documentation within drug development, with emphasis on scientific accuracy; hybrid or on-site role, with flexible work arrangements.