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**Job Description**: **Primary Responsibilities**: - Prepares selected components of regulatory clinical documentation - Develops knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects - Participates, with supervision, on document-specific teams - Develops competence in writing, editing, and reviewing clinical study reports, patient narratives, investigator brochures, and other clinical regulatory documents per company and other guidelines - Acquires a thorough comprehension of medical writing tasks, including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings - Identifies challenges associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members - May participate in initiatives to improve medical writing processes and standards **Education Minimum Requirements**: - Degree in a life science, preferably related to pharmacy or medicine Bachelor’s degree with 2+ years; MS with 1+ year; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with
