Senior Pharmaceutical Writer
6 days ago
We are seeking a highly skilled Regulatory Technical Writer to join our dynamic Regulatory Department at RBW Consulting LLP. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.
About the Position
- 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.
Job Description
- The ideal candidate should possess a degree in Pharmacy, Chemistry, Biology, or a related field.
- A minimum of 5 years of technical writing experience in CMC regulatory submissions is required.
- The candidate should have in-depth knowledge of CMC-related regulatory requirements and guidelines.
- Excellent technical writing skills with the ability to clearly communicate complex scientific information are essential.
- Strong organizational and project management skills to handle multiple tasks simultaneously are required.
- Proficiency in MS Office applications and regulatory information management software is necessary.
- A business level proficiency in written and spoken English is required.
About the Salary
A salary of $125,000 per year is available for this position. Based on your qualifications and experience, your annual salary may range from $110,000 to $160,000.
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