Regulatory Documentation Specialist
3 weeks ago
Job Title: Senior Pharmaceutical Writer
We are seeking a detail-oriented and skilled technical writer to join our team as a Senior Pharmaceutical Writer. This is a fully remote position with occasional travel to our R&D Centre in Paris, France.
In this role, you will be responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets. Your expertise in technical writing and regulatory science will enable us to develop groundbreaking therapies by ensuring the highest quality in regulatory submissions.
Responsibilities:
- Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
- Write CMC sections of regulatory submissions, including Modules 2.
- Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.
- Manage CMC regulatory submission workflows within the document management system.
- Ensure accuracy, consistency, and completeness of data and narratives in regulatory documents.
- Oversee timelines and deliverables for multiple projects, communicating potential delays promptly.
- Provide guidance and training to team members as needed.
Requirements:
- Degree in Pharmacy, Chemistry, Biology, or a related field.
- At least 5 years of technical writing experience in CMC regulatory submissions.
- In-depth knowledge of CMC-related regulatory requirements and guidelines.
- Exceptional technical writing skills with the ability to clearly communicate complex scientific information.
- Strong organizational and project management skills to handle multiple tasks simultaneously.
- Proficiency in MS Office applications and regulatory information management software.
- Business level proficiency in written and spoken English.
Salary: $80,000 - $110,000 per year, depending on experience.
Bonus: Performance-based bonus up to 20% of annual salary.
Benefits: Comprehensive health insurance, retirement plan, paid time off, and flexible work arrangements.
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