Principal Strategic Medical Writer
AbbVie
AbbVie seeks a Principal Strategic Medical Writer to lead clinical and regulatory document development for drug and device programs. The role involves independent writing, team coordination, quality oversight, and regulatory expertise to support submission objectives.
Responsibilities
- Independently prepare clinical and regulatory documents for drug and device development
- Coordinate review, approval, and quality control across functions; conduct review meetings
- Communicate deliverables, timelines, and writing processes to team members
- Lead process improvements and drive team accountability to project deadlines
- Develop expertise in US and international regulatory requirements and guidance
Requirements
- Minimum 5+ years biopharmaceutical industry experience in pharma, biotech, or life sciences
- Bachelor's degree or higher in scientific discipline
- Extensive experience writing clinical and regulatory documents per ICH, GCP guidelines
- Advanced knowledge of drug development, clinical research, biostatistics, and pharmacology
- Outstanding written and oral communication across multiple therapeutic areas
- Ability to manage multiple projects and collaborate across functional teams
- Proficiency in complex data analysis and regulatory requirements
Vacancy posted 5 days ago
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