Associate Director, Medical Writing - San Diego, CA or Remote

PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline. 8 or more years of experience in Medical Writing. Experience in therapeutic areas of immunology and inflammation preferred. Ability to prepare any type of clinical regulatory document. Ability to present clinical data objectively in a clear, concise format.

Serve as medical writing lead on clinical regulatory documents (protocols, IBs, CSRs, briefing documents, IND and NDA modules). Collect and interpret data, analyze literature, and propose solutions. Represent Medical Writing in project meetings and guide cross-functional teams. Serve as Medical Writing contact for external parties (e.g., CROs). Manage multiple document timelines. Collaborate with colleagues, clients, physicians, scientists, and statisticians. Develop and update SOPs, processes, templates, style guides, and manuals. Communicate project updates and risks to senior management and stakeholders. Track regulatory commitments and deliverables. Contribute to responses to health authority requests for information.