Senior Regulatory Content Developer
Há 2 dias
The Senior Regulatory Writing Specialist is a key role in the creation of regulatory materials for investigational and marketed products. This position requires expertise in regulatory writing, with a strong focus on accuracy, consistency, and compliance.
Responsibilities
- Serve as lead writer on regulatory documents, including protocols, CSRs, briefing books, INDs, and NDAs.
- Manage timelines and communications for concurrent writing projects.
- Organize and lead document review meetings with cross-functional teams.
- Ensure clarity, consistency, and accuracy across all assigned deliverables.
- Perform document-level quality control review and contribute to peer reviews.
Requirements
- Advanced degree in a scientific discipline or relevant work experience.
- At least 3 years of experience in scientific/medical/regulatory writing in the pharmaceutical domain.
- Mastery of 3 or more regulatory document types.
Competencies
- Strong attention to detail and analytical skills.
- Ability to interact with other departments and be proficient in written and verbal communication.
- Proficient in Microsoft Office suite.
- Ability to apply regulatory guidelines to content development.
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