Associate Director, Medical Writing - Neuroscience

Associate Director, Medical Writing - Neuroscience

Client is a Large Pharmaceutical Company

The 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 situations
• Preparing and sometimes directing the writing of PCSs, protocols, and amendments
• Preparing and sometimes directing the writing of CSRs, including narratives
• Collaborating across functional areas to gather source materials
• Leading the preparation of clinical sections for submission documents such as briefing books, Investigator Brochures, and regulatory reports
• Leading medical writing activities for marketing application submissions
• Developing document standards and structures in coordination with other groups
• Interacting with clinical research and biostatistics teams to understand study design and results
• Implementing quality controls, standards, and best practices for documents

Job Qualifications

• Bachelor's degree required; Master's preferred
• At least 8 years of medical writing experience in industry, specifically with Neuroscience compounds
• Experience leading or participating in major marketing application submissions
• Strong critical thinking and problem-solving skills
• Self-motivated with influencing abilities
• Ability to manage multiple complex projects
• Effective time management and project planning skills
• Ability to work on-site
• Proficient in MS Project, MS Word, and familiar with Documentum systems

All information will be kept confidential in accordance with EEO guidelines.