About this opportunity
Integrated Resources Inc. lists this Associate Director, Medical Writing - Neuroscience opportunity in woodcliff lake, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
woodcliff lake, NJ, 07677, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.