Medical Writing Science Senior Manager (Hybrid)

Role: Senior Manager in Medical Writing Science, responsible for authoring complex clinical study documents and supporting regulatory submissions across multiple phases of drug development. Responsibilities include leading the creation and review of clinical protocols, study reports, investigator’s brochures, and regulatory meeting documents, while serving as the lead for pivotal studies and providing strategic input for regulatory strategies. Requirements: Ph.D. (or equivalent), 6+ years of experience in clinical regulatory writing, excellent communication skills, and strong knowledge of drug development, study design, biostatistics, and regulatory standards. Preferred qualifications include advanced understanding of clinical research and the ability to lead cross-functional teams. High-value specifics: involvement in complex regulatory documentation supporting global submission processes, collaboration with regulatory agencies, and contributing to advisory committee preparations. The role supports hybrid work arrangements (up to two days remote) and may involve cross-functional interactions within biopharma R&D environments.