Associate Director, Medical Writing - Neuroscience Job ...

Associate Director, Medical Writing - NeuroscienceClient is a Large Pharmaceutical CompanyThe Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing support and direction to staff and contractors on these programs. As the lead writer, the incumbent ensures the timely completion, accuracy, and quality of all clinical and submission documentation throughout the compounds' lifecycle. Due to program complexity, the incumbent must quickly acquire comprehensive knowledge of the compounds to ensure consistency across studies. The candidate should have proven ability to manage outsourcing of document preparation and coordinate with service providers.Responsibilities include but are not limited to:Analyzing complex problems requiring in-depth evaluation of data and situationsPreparing and sometimes directing the writing of PCSs, protocols, and amendmentsPreparing and sometimes directing the writing of CSRs, including narrativesCollaborating across functional areas to gather source materialsLeading the preparation of clinical sections for submission documents such as briefing books, Investigator Brochures, and regulatory reportsLeading medical writing activities for marketing application submissionsDeveloping document standards and structures in coordination with other groupsInteracting with clinical research and biostatistics teams to understand study design and resultsImplementing quality controls, standards, and best practices for documentsJob QualificationsBachelor's degree required; Master's preferredAt least 8 years of medical writing experience in industry, specifically with Neuroscience compoundsExperience leading or participating in major marketing application submissionsStrong critical thinking and problem-solving skillsSelf-motivated with influencing abilitiesAbility to manage multiple complex projectsEffective time management and project planning skillsAbility to work on-siteProficient in MS Project, MS Word, and familiar with Documentum systemsAll information will be kept confidential in accordance with EEO guidelines. #J-18808-Ljbffr

Created: 2025-10-15