- Remote, Serbia
- Remote
- Full-time · Principal
- competitive salary
- 8+ years
Develop high-quality complex clinical and regulatory documents from planning and coordination through to final delivery, ensuring they meet all regulatory requirements and company standards.
Responsibilities
- Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies
- May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
- Provides senior level review of routine and complex documents
- Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
- Ensures compliance with quality processes and requirements for assigned documents
Requirements
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Advanced degree preferred
- Nice to have: AMWA
- Nice to have: EMWA
- Nice to have: RAC