Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)

Role: Medical Writer within the Clinical and Regulatory Strategic Communications (CRSC) team, focusing on preparing high-quality regulated and public-facing clinical documents to support development programs. Responsibilities: independently author and review clinical regulatory documents (e.g., protocols, study reports, investigator brochures) and public-facing materials (e.g., informed consent forms, trial registries), ensuring compliance with evolving regulatory standards; collaborate cross-functionally, contribute to process improvements, and mentor junior staff if needed. Requirements: Bachelor’s degree in life sciences, pharmacy, medicine, or related field; 3+ years of relevant medical writing or industry experience managing multiple projects in fast-paced environments; proficiency in interpreting clinical data and industry regulations; strong communication, critical thinking, and negotiation skills; experience with medical writing tools and platforms. Preferred: experience independently preparing clinical regulatory documents in accordance with regulatory guidelines; knowledge of GxP, ICH GCP, and clinical development. High-Value: focus on clinical trial documentation, regulatory compliance, and health literacy principles; 10% travel; hybrid work setup; clear understanding of clinical development processes and cross-functional team collaboration in biopharma.