Job Summary
A pharmaceutical company is seeking a Remote Dossier Development Associate Director.
Core Responsibilities of this position include:
- Leading and executing CMC writing for clinical (CTA, IND) and marketing applications
- Preparing, reviewing, managing, and leading responses to CMC related questions
- Performing reviews of dossier documents prepared by other team members
Skills and Requirements Include:
- University degree with 6+ years relevant experience is required
- Regulatory CMC writing experience in pharmaceutical biologics
- Excellent written and oral communication skills
- Ability to work in a fast-paced environment and connect with different functional groups
- Strong communication and personal leadership skills
